Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients

NCT ID: NCT02154464

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.

Detailed Description

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This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity

STUDY GOALS

* To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
* To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
* To determine effectiveness of paracetamol IV to reduce postoperative complication rate.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Paracetamol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Perfalgan

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Patients admitted for laparoscopic gastric banding
* Elective surgery
* BMI \> 40
* ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2

Exclusion Criteria

* Patients' refusal to participate in the study
* Patients unable to give an informed consent
* Pregnancy
* Emergent surgery
* Patient with known allergy to morphine or paracetamol
* Patient with hepatic failure (based on history or elevated liver enzymes).
* ASA class \>2.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Alexander Zlotnik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soroka Medical Center, Ben Gurion University of the Negev

Beersheba, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Alexander Zlotnik, M.D. Ph.D.

Role: primary

References

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Semyonov M, Bartulovic A, Cohen N, Berzon B, Fedorina E, Lerman S, Semionov A, Friger M, Acker A, Geftler A, Zlotnik A, Brotfain E. The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. Obesity (Silver Spring). 2022 Nov;30(11):2185-2193. doi: 10.1002/oby.23545. Epub 2022 Sep 25.

Reference Type DERIVED
PMID: 36161276 (View on PubMed)

Other Identifiers

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SOR 0024-14 CTIL

Identifier Type: -

Identifier Source: org_study_id

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