Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

Inonu University

Status and phase: Completed; Phase 4

Conditions: Bariatric Surgery Candidate; Obesity, Morbid

Treatments: Drug: ibuprofen; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02778958

Inonu Medicine Faculty

Details and patient eligibility

About

The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.

Full description

Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery

Exclusion criteria

• Hepatic disfunction,
• Renal failure (creatinine > 3 mg/dL,creatinin clearance < 60 mL/dk or urine out-put < 500 mL/day ) or a history of dialysis 28 days before surgery,
• A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),
• Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,
• A history of opioid addiction or opioid tolerance
• Allergy to study drugs,
• Noncooperative patients for pain assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

ibuprofen and morphine

Experimental group

Description:

iv ibuprofen 800 mg infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Treatment:

Drug: ibuprofen

paracetamol and morphine

Active Comparator group

Description:

iv paracetamol 1 gram infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Treatment:

Drug: paracetamol