Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

Phase 4

Completed

• Conditions: Obesity, Morbid; Bariatric Surgery Candidate
• Interventions: Drug: paracetamol; Drug: ibuprofen

• Registration Number: NCT02778958
• Lead Sponsor: Inonu University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paracetamol and morphine	paracetamol	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)
ibuprofen and morphine	ibuprofen	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)

Primary Outcome Measures

Name	Time	Method
Opioid (morphine) consumption	First 24 hours during postoperative period	iv morphine patient controlled analgesia for multimodal analgesia

Secondary Outcome Measures

Name	Time	Method
Postoperative pain level	First 24 hours during postoperative period	Visual analog scale for evaluation of postoperative pain levels

Trial Locations

Locations (1)

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation; 🇹🇷 Malatya, Turkey