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Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Obesity, Morbid

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
paracetamol
ibuprofen
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring bariatric surgery, morbid obesity, nonopioid analgesics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ibuprofen and morphine

paracetamol and morphine

Arm 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)

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)

Outcomes

Primary Outcome Measures

Opioid (morphine) consumption
iv morphine patient controlled analgesia for multimodal analgesia

Secondary Outcome Measures

Postoperative pain level
Visual analog scale for evaluation of postoperative pain levels

Full Information

First Posted
May 17, 2016
Last Updated
March 12, 2018
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT02778958
Brief Title
Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery
Official Title
Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity, Morbid
Keywords
bariatric surgery, morbid obesity, nonopioid analgesics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen and morphine
Arm Type
Experimental
Arm 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)
Arm Title
paracetamol and morphine
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Description
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
Intervention Name(s)
ibuprofen
Other Intervention Name(s)
İntrafen
Intervention Description
iv ibuprofen flakon, 800 mg; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
Primary Outcome Measure Information:
Title
Opioid (morphine) consumption
Description
iv morphine patient controlled analgesia for multimodal analgesia
Time Frame
First 24 hours during postoperative period
Secondary Outcome Measure Information:
Title
Postoperative pain level
Description
Visual analog scale for evaluation of postoperative pain levels
Time Frame
First 24 hours during postoperative period
Other Pre-specified Outcome Measures:
Title
Side effects
Description
Side effects of study drugs and opioids
Time Frame
First 24 hours during postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay Erdogan Kayhan, MD
Organizational Affiliation
Associated Professor Doctor Gulay ERDOGAN KAYHAN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
City
Malatya
ZIP/Postal Code
44315
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20642488
Citation
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.
Results Reference
result

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Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

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