Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here