Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

NCT ID: NCT02778958

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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

Conditions

Bariatric Surgery Candidate; Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ibuprofen and morphine

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)

Group Type: EXPERIMENTAL

ibuprofen

Intervention Type: DRUG

iv ibuprofen flakon, 800 mg;

iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

paracetamol and morphine

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)

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

iv paracetamol flakon, 1 gram infusion at 30 min;

iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Interventions

paracetamol

iv paracetamol flakon, 1 gram infusion at 30 min;

iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Intervention Type: DRUG

ibuprofen

iv ibuprofen flakon, 800 mg;

iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Intervention Type: DRUG

Other Intervention Names

Acetaminophen; İntrafen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Gulay ERDOGAN KAYHAN

Director of the study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulay Erdogan Kayhan, MD

Role: PRINCIPAL_INVESTIGATOR

Associated Professor Doctor Gulay ERDOGAN KAYHAN

Locations

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.

Reference Type: RESULT

PMID: 20642488 (View on PubMed)

Other Identifiers

Inonu Medicine Faculty

Identifier Type: -

Identifier Source: org_study_id