Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

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

Detailed Description
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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

Official Title
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Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery

Conditions
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Bariatric Surgery Candidate, Obesity, Morbid

Intervention / Treatment
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* Drug: paracetamol
* Drug: ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen and morphine<br>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) | Drug: ibuprofen<br>* iv ibuprofen flakon, 800 mg; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)<br>* Other names: İntrafen;|
| Active Comparator: paracetamol and morphine<br>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) | Drug: paracetamol<br>* iv paracetamol flakon, 1 gram infusion at 30 min; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)<br>* Other names: Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid (morphine) consumption | iv morphine patient controlled analgesia for multimodal analgesia | First 24 hours during postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain level | Visual analog scale for evaluation of postoperative pain levels | First 24 hours during postoperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, morbid obesity, nonopioid analgesics