Pain management for patients undergoing major gastro-intestinal surgery Surgery
Conditions
Interventions
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. lansop
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years and over undergoing major elective gut surgery with bowel anastomosis
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient outcome measures: 1. Number of doses of ibuprofen or other NSAID administered to each patient within 5 days after surgery, measured by reviewing the patient's medical records 2. Clinical effects of oral ibuprofen in reducing pain after major elective gut surgery measured using the Overall Benefit of Analgesia Scores (OBAS) recorded daily for 5 days after surgery 3. Total opioid dose (Oral Morphine Equivalents) within 5 days after surgery, measured by reviewing the patient's medical records 4. Clinical effects of oral ibuprofen in reducing pain after major elective gut surgery measured using the Numeric Rating Scale (NRS) pain scale on postoperative days 1 to 5 5. All complications within 30 days of surgery, measured by reviewing the patient's medical records 6. Mortality within 30 days of surgery, measured by reviewing the patient's medical records 7. Duration of hospital stay within 30 days of surgery, measured by reviewing the patient's medical records 8. Anastomotic leak graded within 30 days of surgery, measured by reviewing the patient's medical records 9. Acute kidney injury (KDIGO creatinine definition only) within 30 days of surgery, measured by reviewing the patient's medical records 10. Gastro-intestinal bleed within 30 days of surgery, measured by reviewing the patient's medical records Hospital-level feasibility outcomes: 1. Number of eligible patients per year in each hospital, measured using screening log data 2. Number of eligible patients randomised per year in each hospital, measured using screening log data 3. Participating hospitals randomising at least one patient within the 12-month recruitment period, measured using enrolment data 4. Number of consultant surgeons and anaesthetists in each hospital who support the recruitment of patients in their care in principle and the total number delivering care for elective colorectal surgery, measured using the feasibility site questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed