ClinicalTrials.gg
CompletedNCT03437707ibuprofenUpdated Sep 5, 2018

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery

An interventional study of Morphine Sulfate and Intravenous paracetamol in Postoperative Pain Management, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 118 studies testing acetaminophen in Pain, Postoperative — 11 open to participants now, 13 under way, 1 of them phase 3. Acetaminophen · Pain, Postoperative.

Enrollment
107th of 118
3 · median 90
Started
2018
with 10 others
No phase
26 of 118
1 open now
Registered
64th of 118
by date
Lead sponsor
3 of 118
Inonu University

Among the 118 studies testing acetaminophen in Pain, Postoperative, this one is the 107th largest by enrollment, is one of 11 that started in 2018, is one of 26 with no phase, and was the 64th registered.

By phase

118 studies; the count open now beside each. This study's row is marked.

Phase 453 · 9 open
No phasethis study26 · 1 open
Phase 320 · 1 open
Phase 29 · 0 open
Phase 17 · 0 open
Phase 2/33 · 0 open

By the year they started

First in 2002; this study’s year is marked. 11 started in 2018.

Size and results

Median enrollment 90 across the 118 interventional studies. Of the 88 that completed or were terminated, 41 (47%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 118 studies testing acetaminophen in Pain, Postoperative, or all of them as a file.
02

Study summary

Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain, and secondary aim is the effects on morphine consumption and side effects of morphine in patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.

Read the detailed description

All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in lumbar disc surgery may reduce complications and improve postoperative care. For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.

Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal anti-inflammatory drugs (NSAID), may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.

Intravenous (IV) ibuprofen is the first and only IV NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

IV paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.

03

Conditions studied

  • Postoperative Pain Management

Browse trials for

Keywords

  • Postoperative pain
  • Intravenous ibuprofen
  • Intravenous paracetamol
  • Lumbar disc surgery
04

Who can participate

Ages eligible
18 Years to 85 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

  • scores 1-3
  • 18-85 years

Exclusion criteria

Exclusion Criteria:

  • scores IV,
  • Under the age of 18,
  • Over the age of 85,
  • Peptic ulcer disease,
  • Hepatic and renal dysfunction,
  • Severe cardiovascular and pulmonary disease,
  • Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
  • Emergency surgery,
  • Refused form
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3 participants (actual)

Study arms

  • Placebo comparator
    placebo

    250 ml saline will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Drug: Morphine Sulfate

  • Active comparator
    Intravenous paracetamol

    1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Drug: Morphine Sulfate · Drug: Intravenous paracetamol

  • Active comparator
    Intravenous ibuprofen

    800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Drug: Morphine Sulfate · Drug: Intravenous ibuprofen

Interventions

  • Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Also known as: Intravenous patient-controlled analgesia

  • 1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Also known as: paracetamol

  • 800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

    Also known as: ibuprofen

06

What researchers measure

Primary outcomes

  1. Postoperative pain scores

    Visual Analog Scale (VAS, 0-10)

    Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

Secondary outcomes

  1. Sedation score

    Ramsey sedation score (1-6)

    Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

  2. Morphine consumption

    Morphine

    Time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

07

Study locations

1 site
  • Sedat AKBAS
    Malatya, Türkiye-Türkçe 44090, Turkey
08

References and documents

Publications

  • Tunali Y, Akcil EF, Dilmen OK, Tutuncu AC, Koksal GM, Akbas S, Vehid H, Yentur E. Efficacy of intravenous paracetamol and dexketoprofen on postoperative pain and morphine consumption after a lumbar disk surgery. J Neurosurg Anesthesiol. 2013 Apr;25(2):143-7. doi: 10.1097/ANA.0b013e31827464af. PubMed 23360885 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437707
Lead sponsor
Inonu University
Responsible party
Sedat AKBAS (Asst. Prof., Inonu University) — Principal investigator
First posted
Feb 19, 2018
Start date
Feb 13, 2018
Primary completion
Aug 6, 2018
Completion
Aug 13, 2018
Last update
Sep 5, 2018

Study contacts

Sedat AKBAS
study director · Inonu University Medical Faculty

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Acetaminophen · Ibuprofen

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