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CompletedNCT03428230Updated Jun 24, 2021Results posted

Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures

A Phase 2 interventional study of 30 mg Paracetamol 3% (1 mL) and 60 mg Paracetamol 3% (2 mL) in Pain, Postoperative, sponsored by Sintetica SA. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Sintetica SA · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a phase II, single centre, randomised, parallel-group, double-blind, three doses, placebo-controlled, exploratory efficacy and safety study. The objective of this study is to investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30 mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for post-operative analgesia in knee procedures up to 40 min duration performed under spinal anaesthesia with Chloroprocaine HCl 1%.

Read the detailed description

Eligible patients undergoing elective short-duration knee procedures up to 40 min duration will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of Paracetamol 3% (D1: 30 mg, D2: 60 mg, D3: 90 mg) or the placebo solution (P: 0.9% saline solution) by intrathecal injection (IT), according to the randomised, parallel-group design.

Immediately after IT paracetamol or placebo administration, all patients will receive a single IT dose of Chloroprocaine HCl 1% (Non-investigational medicinal product, NIMP) according to the Summary of Product Characteristics indications. The time interval between paracetamol IT and chloroprocaine IT injections should not exceed 2 min.

The study will include a screening phase (Visit 1, Day -21/-1), a treatment phase (IMP IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3), a final visit and two follow-ups (24 h post-dose and day 7±1).

02

Conditions studied

  • Pain, Postoperative

Browse trials for

03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Sintetica SA is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. : signed written informed consent before inclusion in the study
  2. Sex, age and surgery: male/female patients, 18-80 years old (inclusive), scheduled for short duration (up to 40 min) knee procedures
  3. (BMI): 18 - 32 kg/m2 inclusive
  4. : I-III
  5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.

Exclusion criteria

Exclusion Criteria:

  1. Physical findings: abnormal physical findings which could interfere with the objectives of the study. to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
  2. : IV-V
  3. Further anaesthesia: patients expected to require further anaesthesia
  4. Allergy: ascertained or presumptive to the active principles (paracetamol and/or ester type anaesthetics) and/or formulations' ingredients or related drugs, non-steroidal anti-inflammatory drugs and/or opioid derivatives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
  5. Chronic pain syndromes: patients with chronic pain syndromes taking opioids, anticonvulsant agents or chronic analgesic therapy
  6. Pain assessment: patients anticipated to be unable to make a reliable self-report of pain intensity
  7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes, other neuropathies, history or evidence of heart failure. History of severe head trauma that required hospitalisation, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion
  8. Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Paracetamol formulations, other than the product, for 2 weeks before the start of the study and during the study. Hormonal for females are allowed. Anti-hypotensive, anti-bradycardia (e.g. ephedrine, atropine, Ringer's solution), anti-haemetic and anti-nausea medications will be allowed
  9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
  10. Drug, alcohol: history of drug or alcohol abuse according to the Investigator's opinion
  11. Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating women [The pregnancy test will be performed to all fertile women and to all women up to 55 years old, if not in proven menopause (available laboratory test confirming menopause or surgically sterilised)]
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    30 mg Paracetamol 3% (1 mL)

    30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT)

    Drug: 30 mg Paracetamol 3% (1 mL) · Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection

  • Experimental
    60 mg Paracetamol 3% (2 mL)

    60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT)

    Drug: 60 mg Paracetamol 3% (2 mL) · Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection

  • Experimental
    90 mg Paracetamol 3% (3 mL)

    90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT)

    Drug: 90 mg Paracetamol 3% (3 mL) · Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection

  • Placebo comparator
    Placebo, 0.9% saline solution

    Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT)

    Drug: Placebo, 0.9% saline solution · Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection

Interventions

  • Drug30 mg Paracetamol 3% (1 mL)

    Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.

  • Drug60 mg Paracetamol 3% (2 mL)

    Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.

  • Drug90 mg Paracetamol 3% (3 mL)

    Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.

  • DrugPlacebo, 0.9% saline solution

    Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.

    Also known as: physiological solution

  • DrugNIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection

    Drug page: Chloroprocaine

    Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.

    Also known as: Ampres 1%

06

What researchers measure

Primary outcomes

  1. Pain Intensity at Rest Evaluated Using a 0-100 mm VAS

    The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain)

    Time frame: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.

Secondary outcomes

  1. Pain at Rest AUCt1-t2

    AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals

    Time frame: Up to 4 hours after injection

  2. Pain at Rest AUClast

    AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time

    Time frame: Up to 24 hours after injection

  3. Time to First Postoperative Analgesia (Level 1 or 2)

    Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. \[Toradol\] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. \[Toradol\] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia).

    Time frame: Up to 24 hours after surgery

  4. Partecipants to Received Level 1 Analgesia

    Partecipants to received Ketorolac i.v. \[Toradol\] 30 mg administration (level 1 analgesia)

    Time frame: from surgery day to 24 hours after surgery

  5. Partecipants Received Level 2 Analgesia

    Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia)

    Time frame: from surgery day to 24 hours after surgery

  6. Total Number of Partecipants Receiving Analgesic 1

    Total number of partecipants receiving Ketorolac i.v. \[Toradol\] 30 mg

    Time frame: From surgery day to 24 hours after surgery

  7. Total Number of Partecipants Receiving Analgesic 2

    Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg

    Time frame: from surgery day to 24 hours after surgery

  8. Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End

    Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end

    Time frame: Form surgery day to 2 hours after surgery end

  9. Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End

    Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end

    Time frame: from surgery day to 4 hours after surgery end

  10. Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge

    Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge

    Time frame: from surgery day to 24 hours after surgery

  11. Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge

    Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge

    Time frame: from surgery day to 24 hours after surgery

  12. Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge

    Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge

    Time frame: from surgery day to 24 hours after surgery

  13. Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia

    Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia

    Time frame: from surgery day to 24 hours after surgery

  14. Percentage of Patients Requiring Rescue Anaesthesia

    Percentage of patients requiring rescue anaesthesia

    Time frame: from surgery day to 1 hour after injection

  15. Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)

    Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery.

    Time frame: Up to 20 minutes after injection

  16. Maximum Sensory Block

    Maximum level of sensory block

    Time frame: Intraoperative

  17. Time to Sensory Block

    Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle)

    Time frame: Intraoperative

  18. Time to Regression of Spinal Block

    Time period from spinal injection to the complete regression of sensory block to S1.

    Time frame: Up to 4 hours after injection

  19. Time to Ambulation

    Time to unassisted ambulation

    Time frame: Up to 24 hours after injection

  20. Time to First Urine

    Time to first spontaneous urine voiding

    Time frame: Up to 24 hours after injection

  21. Time to Eligibility for Discharge

    Time to eligibility for home discharge

    Time frame: Up to 24 hours after injection

Other outcomes

  1. Number of Participants With Neurological Complications Including TNS

    Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1

    Time frame: From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery)

07

Results

Posted Jun 24, 2021

Participant flow

Participant flow — Overall Study
Milestone30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Started15151515
Completed15151515
Not completed0000

Outcome measures

PrimaryPain Intensity at Rest Evaluated Using a 0-100 mm VAS

The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain)

Time frame:
Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.
Reported as:
Mean · score on a scale
Pain Intensity at Rest Evaluated Using a 0-100 mm VAS
score on a scale30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
baseline9.6 ± 2016.9 ± 17.418.4 ± 26.48.1 ± 14.8
1 hour after NIMP0.1 ± 0.30.1 ± 0.53.4 ± 11.50 ± 0
1.25 hour after NIMP4.6 ± 11.41.9 ± 5.16.2 ± 13.70.6 ± 1.3
1.50 hour after NIMP5.9 ± 13.24.5 ± 10.216.4 ± 23.61.2 ± 2.1
1.75 hour after NIMP9.5 ± 16.515.1 ± 16.321.4 ± 24.33.6 ± 6.1
2 hours after NIMP14.1 ± 24.617.8 ± 1922.8 ± 23.23.9 ± 8.7
2.5 hours after NIMP16.9 ± 22.88.7 ± 7.114.7 ± 15.87.2 ± 8.2
3 hours after NIMP21 ± 27.79.6 ± 12.87.3 ± 1310.4 ± 15.4
3.5 hours after NIMP19.7 ± 21.46.8 ± 11.414.2 ± 25.711.4 ± 16.8
4 hours after NIMP6.8 ± 8.313.3 ± 18.115.3 ± 19.10 ± 0
4.5 hours after NIMP2.5 ± 3.50 ± 02 ± 2.60 ± 0
before discharge3.7 ± 4.74.1 ± 5.62.9 ± 4.511.3 ± 7.7
SecondaryPain at Rest AUCt1-t2

AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals

Time frame:
Up to 4 hours after injection
Reported as:
Mean · score on a scale*h
Pain at Rest AUCt1-t2
score on a scale*h30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
AUC 0-2 hours13 ± 1314.8 ± 12.526.4 ± 30.14.4 ± 7.1
AUC 0-4 hours34.6 ± 29.626 ± 10.992.2 ± 69.449.7 ± 21.7
SecondaryPain at Rest AUClast

AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time

Time frame:
Up to 24 hours after injection
Reported as:
Mean · score on a scale*h
Pain at Rest AUClast
score on a scale*h30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Pain at Rest AUClast34 ± 41.324.7 ± 15.742 ± 50.315.7 ± 23.3
SecondaryTime to First Postoperative Analgesia (Level 1 or 2)

Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. \[Toradol\] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. \[Toradol\] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia).

Time frame:
Up to 24 hours after surgery
Reported as:
Count of participants · Participants
Time to First Postoperative Analgesia (Level 1 or 2)
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
0-2 hours5370
0-4 hours6571
SecondaryPartecipants to Received Level 1 Analgesia

Partecipants to received Ketorolac i.v. \[Toradol\] 30 mg administration (level 1 analgesia)

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Partecipants to Received Level 1 Analgesia
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Partecipants to Received Level 1 Analgesia6571
SecondaryPartecipants Received Level 2 Analgesia

Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia)

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Partecipants Received Level 2 Analgesia
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Partecipants Received Level 2 Analgesia2040
SecondaryTotal Number of Partecipants Receiving Analgesic 1

Total number of partecipants receiving Ketorolac i.v. \[Toradol\] 30 mg

Time frame:
From surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Total Number of Partecipants Receiving Analgesic 1
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Total Number of Partecipants Receiving Analgesic 16571
SecondaryTotal Number of Partecipants Receiving Analgesic 2

Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Total Number of Partecipants Receiving Analgesic 2
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Total Number of Partecipants Receiving Analgesic 22040
SecondaryPercentage of Patients Requiring Analgesia in the First 2 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end

Time frame:
Form surgery day to 2 hours after surgery end
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End5370
SecondaryPercentage of Patients Requiring Analgesia in the First 4 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end

Time frame:
from surgery day to 4 hours after surgery end
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End6571
SecondaryPercentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge6571
SecondaryPercentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge6571
SecondaryPercentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge2040
SecondaryPercentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia

Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia

Time frame:
from surgery day to 24 hours after surgery
Reported as:
Number · participants
Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia
participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
level 16571
level 22040
SecondaryPercentage of Patients Requiring Rescue Anaesthesia

Percentage of patients requiring rescue anaesthesia

Time frame:
from surgery day to 1 hour after injection
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Rescue Anaesthesia
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Percentage of Patients Requiring Rescue Anaesthesia14151514
SecondaryTime to Onset of Spinal Block (i.e. Time to Readiness for Surgery)

Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery.

Time frame:
Up to 20 minutes after injection
Reported as:
Median · minutes
Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)5 (2 to 5)5 (3 to 5)2 (1 to 5)5 (2 to 5)
SecondaryMaximum Sensory Block

Maximum level of sensory block

Time frame:
Intraoperative
Reported as:
Count of participants · Participants
Maximum Sensory Block
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
T10000
T21000
T30000
T40011
T50111
T61111
T70100
T87066
T90320
T103514
T112321
T120101
L11010
L20000
L30000
L40000
L50000
S10000
S20000
S30000
S40000
S50000
SecondaryTime to Sensory Block

Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle)

Time frame:
Intraoperative
Reported as:
Median · minutes
Time to Sensory Block
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to Sensory Block10 (10 to 12)10 (8 to 14)10 (5 to 10)10 (6 to 15)
SecondaryTime to Regression of Spinal Block

Time period from spinal injection to the complete regression of sensory block to S1.

Time frame:
Up to 4 hours after injection
Reported as:
Median · minutes
Time to Regression of Spinal Block
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to Regression of Spinal Block100 (85 to 112)100 (78 to 125)90 (76 to 95)95 (89 to 115)
SecondaryTime to Ambulation

Time to unassisted ambulation

Time frame:
Up to 24 hours after injection
Reported as:
Median · minutes
Time to Ambulation
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to Ambulation139 (120 to 180)115 (65 to 150)125 (95 to 170)125 (120 to 165)
SecondaryTime to First Urine

Time to first spontaneous urine voiding

Time frame:
Up to 24 hours after injection
Reported as:
Median · minutes
Time to First Urine
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to First Urine155 (122 to 220)140 (87 to 205)145 (100 to 177)150 (125 to 170)
SecondaryTime to Eligibility for Discharge

Time to eligibility for home discharge

Time frame:
Up to 24 hours after injection
Reported as:
Median · minutes
Time to Eligibility for Discharge
minutes30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Time to Eligibility for Discharge170 (145 to 230)165 (132 to 195)170 (135 to 200)168 (145 to 190)
Other pre-specifiedNumber of Participants With Neurological Complications Including TNS

Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1

Time frame:
From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery)
Reported as:
Count of participants · Participants
Number of Participants With Neurological Complications Including TNS
Participants30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
Number of Participants With Neurological Complications Including TNS0000

Adverse events

Collected over Adverse events throughout the study 48 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
30 mg Paracetamol 3% (1 mL)0/15 (0%)0/15 (0%)3/15 (20%)
60 mg Paracetamol 3% (2 mL)0/15 (0%)0/15 (0%)0/15 (0%)
90 mg Paracetamol 3% (3 mL)0/15 (0%)0/15 (0%)4/15 (26.7%)
Placebo, 0.9% Saline Solution0/15 (0%)0/15 (0%)3/15 (20%)
Most frequent other events
Most frequent other events
Event30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline Solution
headacheNervous system disorders3/150/151/151/15
hypotensionVascular disorders0/150/152/151/15
bradycardiaCardiac disorders0/150/151/151/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline SolutionTotal
Mean46.1 ± 10.939.7 ± 15.540.1 ± 12.845.5 ± 13.642.85 ± 13.2
Sex: Female, Male
Sex: Female, Male(Participants)30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline SolutionTotal
Female22228
Male1313131352
Race (NIH/OMB)
Race (NIH/OMB)(Participants)30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline SolutionTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White1515151560
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)30 mg Paracetamol 3% (1 mL)60 mg Paracetamol 3% (2 mL)90 mg Paracetamol 3% (3 mL)Placebo, 0.9% Saline SolutionTotal
Switzerland1515151515
08

Study locations

1 site
  • Department of Anaesthesiology, Clinica Ars Medica
    Gravesano, 6929, Switzerland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Oct 2019, 14 months.

Results were first posted in Jun 2021, 1 year 8 months after primary completion.

Of 49 industry-sponsored phase 2 interventional studies under Pain, Postoperative, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 14 months is above that.

Counting every sponsor, half of 140 studies reached it within 12 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Feb 9, 2018
StartActual
Aug 6, 2018
Primary completionActual
Oct 22, 2019
CompletionActual
Oct 22, 2019
Results first posted
Jun 24, 2021
Last update
Jun 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03428230
Lead sponsor
Sintetica SA
Collaborators
Cross Research S.A.
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Aug 6, 2018
Primary completion
Oct 22, 2019
Completion
Oct 22, 2019
Results posted
Jun 24, 2021
Last update
Jun 24, 2021

Study contacts

Claudio Camponovo, MD
principal investigator · Department of Anaesthesiology, Clinica Ars Medica, Via Cantonale, CH-6929 Gravesano, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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