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Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02778958
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Gulay ERDOGAN KAYHAN, 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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Obesity, Morbid Drug: paracetamol Drug: ibuprofen Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery
Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: ibuprofen

iv ibuprofen flakon, 800 mg;

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

Other Name: İntrafen

Active Comparator: 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)
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)

Other Name: Acetaminophen




Primary Outcome Measures :
  1. Opioid (morphine) consumption [ Time Frame: First 24 hours during postoperative period ]
    iv morphine patient controlled analgesia for multimodal analgesia


Secondary Outcome Measures :
  1. Postoperative pain level [ Time Frame: First 24 hours during postoperative period ]
    Visual analog scale for evaluation of postoperative pain levels


Other Outcome Measures:
  1. Side effects [ Time Frame: First 24 hours during postoperative period ]
    Side effects of study drugs and opioids



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778958


Locations
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Turkey
Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
Malatya, Turkey, 44315
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Gulay Erdogan Kayhan, MD Associated Professor Doctor Gulay ERDOGAN KAYHAN
Publications of Results:
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Responsible Party: Gulay ERDOGAN KAYHAN, Director of the study, Inonu University
ClinicalTrials.gov Identifier: NCT02778958    
Other Study ID Numbers: Inonu Medicine Faculty
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gulay ERDOGAN KAYHAN, Inonu University:
bariatric surgery
morbid obesity
nonopioid analgesics
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action