NCT02778958

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

May 17, 2016

Last Update Submit

March 12, 2018

Conditions

Bariatric Surgery CandidateObesity, Morbid

Keywords

bariatric surgerymorbid obesitynonopioid analgesics

Outcome Measures

Primary Outcomes (1)

  • Opioid (morphine) consumption

    iv morphine patient controlled analgesia for multimodal analgesia

    First 24 hours during postoperative period

Secondary Outcomes (1)

  • Postoperative pain level

    First 24 hours during postoperative period

Other Outcomes (1)

  • Side effects

    First 24 hours during postoperative period

Study Arms (2)

ibuprofen and morphine

EXPERIMENTAL

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

paracetamol and morphine

ACTIVE COMPARATOR

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

Interventions

paracetamolDRUG

iv paracetamol flakon, 1 gram infusion at 30 min; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)

Also known as: Acetaminophen
paracetamol and morphine
ibuprofenDRUG

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

Also known as: İntrafen
ibuprofen and morphine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Malatya, 44315, Turkey (Türkiye)

Location

Related 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):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.

    PMID: 20642488RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Gulay Erdogan Kayhan, MD

    Associated Professor Doctor Gulay ERDOGAN KAYHAN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the study

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 20, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)