Pain management using ibuprofen after major gut surgery (PROTECT-AEGIS)

Analgesia with ibuprofen for patients undergoing elective major gastro-intestinal surgery

Registry ID
ISRCTN18046426
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
INTERVENTIONAL
Sponsor
Queen Mary University of London
Enrollment
200
Start date
2026-03-17
Completion date
2027-06-30
Last update
2026-08-17

Conditions

Summary

Pain management for patients undergoing major gastro-intestinal surgery

Detailed description

Oral ibuprofen 400 mg three times daily for 5 days, started on postoperative day one, plus usual analgesic measures (epidural, patient-controlled analgesia, etc) and proton pump inhibitor (e.g. lansoprazole).

Interventions

Inclusion criteria

Patients aged 18 years and over undergoing major elective gut surgery with bowel anastomosis

Exclusion criteria

1. Inability or refusal to provide informed consent 2. Previous enrolment in the PROTECT-AEGIS trial 3. Concomitant administration of any of the below: 3.1. Another Non-Steroidal Anti-Inflammatory Drug 3.2. Mifepristone within 2 weeks before surgery 4. History of specific risk factors: 4.1. Severe organ dysfunction defined as American Society of Anaesthesiologists (ASA) Physical Status Classification System 4 and/or eGFR <45 4.2. Known hypersensitivity or allergic reactions to ibuprofen (or its excipients), or other Non-Steroidal Anti-Inflammatory Drugs 4.3. Peptic ulcer disease: two or more episodes of proven ulceration or bleeding, or upper gastrointestinal perforation 4.4. Third trimester of pregnancy 4.5. Solid organ or bone marrow transplant

Locations

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