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Completed

NCT Number: NCT02778958

Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery

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

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Malatya, 44315, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

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)

Other names: Acetaminophen

Ibuprofen

Drug

iv ibuprofen flakon, 800 mg;

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

Other names: İntrafen

Primary outcomes

  1. Opioid (morphine) consumption

    Time frame: First 24 hours during postoperative period

    iv morphine patient controlled analgesia for multimodal analgesia

Secondary outcomes

  1. Postoperative pain level

    Time frame: First 24 hours during postoperative period

    Visual analog scale for evaluation of postoperative pain levels

Other outcomes

  1. Side effects

    Time frame: First 24 hours during postoperative period

    Side effects of study drugs and opioids

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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