Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778958
• Other study ID #: Inonu Medicine Faculty
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2016
• Last updated: March 12, 2018
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid

Intervention

Drug:
• 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)
• ibuprofen
iv ibuprofen flakon, 800 mg; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Locations

Country	Name	City	State
Turkey	Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Side effects of study drugs and opioids	First 24 hours during postoperative period
Primary	Opioid (morphine) consumption	iv morphine patient controlled analgesia for multimodal analgesia	First 24 hours during postoperative period
Secondary	Postoperative pain level	Visual analog scale for evaluation of postoperative pain levels	First 24 hours during postoperative period