Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07070050

Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial

Led by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology · Updated on 2025-07-17

100

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of continuous infusion versus bolus injection of ibuprofen, a common non-steroidal anti-inflammatory drug (NSAID), for pain management after elective laparoscopic surgery. The study focuses on improving postoperative pain control while reducing opioid use, following the Enhanced Recovery After Surgery (ERAS) guidelines. This Phase 4 trial aims to provide evidence on the effectiveness and safety of continuous ibuprofen infusion, which has not been extensively studied compared to other NSAIDs like paracetamol and ketoprofen. Participants will receive either an experimental continuous infusion or a bolus injection of ibuprofen during their postoperative care. In the continuous infusion group, patients receive an initial bolus dose of 400 mg ibuprofen intravenously, followed by a continuous infusion of ibuprofen over the first two days with doses adjusted by ideal body weight. The bolus injection group also starts with a 400 mg intravenous bolus, then receives three 800 mg bolus injections every eight hours on the first and second days. Placebo infusions or injections are given to maintain blinding between groups. During the study, participants will be monitored for opioid consumption up to 28 days after surgery, which is the primary outcome. Pain intensity will be assessed from admission to the intensive care unit until 48 hours postoperatively. Safety assessments include evaluating liver and kidney function, allergy history, and other health conditions relevant to NSAID use. This randomized, triple-blind trial involves regular intravenous treatments and close observation to understand the benefits and risks of continuous ibuprofen infusion compared to bolus dosing after laparoscopic surgery.

CONDITIONS

Brief Title

Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years old
  • Scheduled for elective laparoscopic surgery
  • Planned general anesthesia
  • Signed informed consent to participate
  • RASS scale between -2 and +1 on admission to surgical department or ICU
Not Eligible

You will not qualify if you...

  • History of ibuprofen allergy
  • Active erosive or ulcerative gastrointestinal lesions
  • Chronic opioid or NSAID use before enrollment
  • Chronic kidney disease stage 3b or higher
  • Liver dysfunction with ALT or AST levels three times above normal
  • History of bronchial asthma
  • History of hereditary blood clotting disorders
  • Use of anticoagulant medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 days

Participants receive either continuous infusion or bolus injection of ibuprofen after laparoscopic surgery as part of multimodal analgesia.

Multiple intravenous administrations over 2 days

Follow-up

Duration - Up to 28 days

Participants are monitored for opioid consumption and pain intensity after treatment.

Follow-up visits and assessments up to 28 days

Trial Site Locations

Total: 1 location

1

City Clinical Hospital named after S.S. Yudin

Moscow, Moscow Oblast, Russia, 115446

Actively Recruiting

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Research Team

V

Valery Likhvantsev, PhD

K

Kristina Kadantseva, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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