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CompletedNCT05483647Updated Aug 4, 2022

ERECTOR SPINE PLANE BLOCK VERSUS LOCAL INFILTRATION ANAESTHESIA FOR TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY

An interventional study of Local infiltrative anaesthesia and Erector spine plane block in Acute Pain, Chronic Pain and Postoperative Pain, sponsored by Lviv National Medical University. Completed at 1 site in Ukraine. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Lviv National Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The main aim of our study was to test the hypothesis that Erector spine plane block (ESP) with sedation will provide the similar employment of fentanyl and propofol during surgery as an infiltrative local anaesthesia with sedation. The primary endpoint was the quantity of fentanyl and propofol during surgery.

Read the detailed description

Primary outcome: amount of fentanyl and propofol during surgery. Secondary outcomes: adverse events during sedation using World Society of Intravenous Anaesthesia (SIVA) adverse sedation event reporting tool [15], level of postoperative sedation with Richmond Agitation-Sedation Scale (RASS), intensity of pain after surgery using a visual analogue scale (VAS), the mechanical pain threshold (MPT) with von Frey monofilaments measured on both lower extremities, satisfaction with analgesia using 5-point Likert scale.

In both groups, intraoperative analgesia was provided by fentanyl, intraoperative sedation by propofol. Fentanyl was administered to the patients of booth groups in the case of low back pain complaint and/or increasing in heart rate and blood pressure more than 20% of baseline in the dose of 50 μg. If case of sharp shooting pain in lower extremity the surgeon changed the position of the endoscope in order not to irritate the spinal cord root, fentanyl was not administrated.

After performing the local infiltrative anaesthesia or ESP, propofol was given by target-controlled infusion based on the propofol pharmacokinetic parameters reported by Eleveld 2.1 [16]. The initial propofol plasma concentration target was 1,0 μg ml-1 in both groups (we used iTIVA plus Anaesthesia software v5.2.3 to predict the propofol concentrations). Subsequently, the infusion rate of propofol was changed in order to reach not less than 2-3 score levels of modified observer's assessment of alertness/sedation scale (MOAA/S).

During procedural sedation was used World SIVA adverse sedation event reporting tool. All five steps which require this tool were completed. If there were one or more adverse events associated with this sedation encounter (minimal risk descriptors, minor risk descriptors, sentinel risk descriptors or other) they were described. Interventions that were performed to treat the adverse events and the outcomes of the adverse events were also noted.

After the discharge from the operating room to postoperative ward, the level of postoperative sedation was accessed using RASS. Two hours after surgery intensity of pain and the mechanical pain threshold were obtained as well as satisfaction with analgesia using 5-point Likert scale.

To determine the mechanical pain threshold after surgery Von Frey monofilaments were used. The set consists of 20 nylon filaments of different thicknesses in ascending order. Patients were asked to lie down on their backs, close their eyes and inform the doctor when they felt a clear point of contact with the skin. Monofilaments were pressed against the skin of the middle third of the palmar surface of the forearm at an angle of 90 ° until the filament bends for 2 seconds. Monofilaments were used in ascending order with an interval of 10 seconds.

All patients in the operating room received paracetamol, dexketoprofen, ondansetron, dexamethasone, and tranexamic acid. In prone position, before the skin incision, patients in G1 underwent local infiltrative anaesthesia et the level of incision. The skin, subcutaneous tissue and muscles up to the foramen intervertebral were anesthetized by the surgeon employing forty millilitre solution of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018%. Patients in G2 underwent bilateral ESP. The transverse vertebral process of the required level of spine was identified using the mobile C-arm X-ray System. When the tip of the 22G needle reached to the transverse vertebral process 3 cm lateral to the spinous process, a solution of 40 millilitres of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018% was injected under the erector spinae muscle bilaterally. For postoperative analgesia, patients in both groups received nonsteroidal anti-inflammatory drugs (paracetamol in combination with dexketoprofen) every six hours. Thromboprophylaxis was administered based on the risk of thromboembolic complications.

Duration of observation of the patients was proceed until discharge from the hospital.

02

Conditions studied

  • Acute Pain
  • Chronic Pain
  • Postoperative Pain
  • Anesthesia
  • Regional Anesthesia Morbidity
  • Anesthesia, Local
  • Anesthesia Complication
  • Hyperalgesia
  • Intraoperative Complications
  • Intraoperative Neurological Injury
  • Intraoperative Injury
  • Postoperative Nausea and Vomiting
  • Postoperative Cognitive Dysfunction
  • Neuropathic Pain

Keywords

  • ERECTOR SPINE PLANE BLOCK
  • Regional anesthesia
  • LOCAL INFILTRATION ANAESTHESIA
  • TRANSFORAMINAL PERCUTANEOUS ENDOSCOPIC DISCECTOMY
03

In context

Acute Pain

1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.

This study's enrollment of 52 is below the median of 86 across 902 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Lviv National Medical University is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: of the patient to participate in the study, intervertebral hernia that require transforaminal percutaneous endoscopic discectomy, and the absence of known allergies to local anaesthetics.

Exclusion Criteria: refusal to participate in the study both at the beginning of the study and at any stage of the study, physical status according to the III and more, age more than 50 years old, (BMI) more than 30 kg/m2.

Terms in these criteria, in plain language(3)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    G1

    Intravenous sedation with infiltrative local anaesthesia

    Procedure: Local infiltrative anaesthesia

  • Experimental
    G2

    Intravenous sedation with bilateral Erector Spine Plane Block

    Procedure: Erector spine plane block

Interventions

  • ProcedureLocal infiltrative anaesthesia

    In prone position, before the skin incision, patients in G1 underwent local infiltrative anaesthesia et the level of incision. The skin, subcutaneous tissue and muscles up to the foramen intervertebral were anesthetized by the surgeon employing forty millilitre solution of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018%.

  • ProcedureErector spine plane block

    The transverse vertebral process of the required level of spine was identified using the mobile C-arm X-ray System. When the tip of the 22G needle reached to the transverse vertebral process 3 cm lateral to the spinous process, a solution of 40 millilitres of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine 0.00018% was injected under the erector spinae muscle bilaterally.

06

What researchers measure

Primary outcomes

  1. Amount of fentanyl and propofol during surgery

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Adverse events during sedation using World Society of Intravenous Anaesthesia adverse sedation event reporting tool

    Time frame: Through study completion, an average of 1 year

  2. Level of postoperative sedation with Richmond Agitation-Sedation Scale

    Time frame: Through study completion, an average of 1 year

  3. Intensity of pain after surgery using a visual analogue scale

    Time frame: On hour after surgery

  4. The mechanical pain threshold with von Frey monofilaments measured on both lower extremities

    Time frame: Baseline, on the 1st day after surgery

  5. Satisfaction with analgesia using 5-point Likert scale.

    Time frame: On the 5st day after surgery

07

Study locations

1 site
  • Rivne Oblast State Hospital
    Rivne, Rivne Region 33000, Ukraine
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05483647
Lead sponsor
Lviv National Medical University
Responsible party
Maksym Barsa (Doctor, Lviv National Medical University) — Principal investigator
First posted
Aug 2, 2022
Start date
Jan 1, 2021
Primary completion
Jan 1, 2022
Completion
Jul 5, 2022
Last update
Aug 4, 2022

Oversight

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

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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