Continuous versus bolus ibuprofen for pain after laparoscopic surgery
Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial
This trial tests whether giving ibuprofen as a continuous infusion instead of intermittent bolus doses reduces pain and opioid use for adults having elective laparoscopic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology Academic / other |
| Locations | 1 site (Moscow, Moscow Oblast) |
| Trial ID | NCT07070050 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study compares continuous infusion of ibuprofen with standard bolus injections as part of multimodal analgesia after elective laparoscopic surgery in adults. Eligible patients (>18 years) who undergo general anesthesia and meet safety criteria will receive either a continuous postoperative ibuprofen infusion or intermittent bolus dosing, with pain scores, analgesic consumption, and adverse events recorded. The protocol is aligned with ERAS principles to minimize opioid use while monitoring for NSAID-related side effects such as bleeding, renal dysfunction, or liver enzyme elevations. Enrollment is limited to patients admitted to the participating hospital and requires a RASS score between -2 and +1 on admission.
Who should consider this trial
Good fit: Adults scheduled for elective laparoscopic surgery under general anesthesia who can give informed consent and do not have contraindications to ibuprofen (no allergy, no significant kidney or liver disease, no active GI ulcers, no asthma or coagulopathy, not on anticoagulants or chronic opioids/NSAIDs).
Not a fit: Patients with ibuprofen allergy, active erosive or ulcerative gastrointestinal disease, chronic kidney disease stage ≥3b, marked liver dysfunction, asthma, hereditary coagulopathies, current anticoagulant use, or chronic opioid/NSAID use are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve postoperative pain control and reduce opioid requirements after laparoscopic surgery.
How similar studies have performed: Previous studies of continuous perioperative NSAID infusion have produced mixed results, with some showing improved analgesia and opioid-sparing and others finding no clear advantage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years old * Elective laparoscopic surgery * General anesthesia * Signed informed consent from the patient to participate in the study * RASS scale from -2 to +1 on admission to a surgical department or ICU Exclusion Criteria: * History of ibuprofen allergy * Active erosive or ulcerative lesions of the gastrointestinal tract * Chronic use of opioid analgesics or NSAIDs prior to enrollment * Chronic kidney disease ≥ 3b stage according to the KDIGO classification * Liver dysfunction (three times exceeding the upper reference limit of ALT or AST) * A history of bronchial asthma * A history of hereditary coagulopathies * A history of use of anticoagulants
Where this trial is running
Moscow, Moscow Oblast
- City Clinical Hospital named after S.S. Yudin — Moscow, Moscow Oblast, Russia (Recruiting)
Study contacts
- Principal investigator: Valery Likhvantsev, PhD — Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
- Study coordinator: Valery Likhvantsev, PhD
- Email: lik0704@gmail.com
- Phone: +79036235982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.