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

NCT02154464 | Unknown DMC

• 1 other identifier: SOR 0024-14 CTIL
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Morphine-sparing; Paracetamol; Obesity; Gastric banding

Outcome Measures

Primary Outcomes (1)

• amount of morphine

  The primary outcome will be the comparison amount of morphine injected in each group until discharge

  Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)

Secondary Outcomes (4)

• Complication during treatment of patient in PACU:

  Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)

• Time discharging from PACU

  Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)

• Length of hospitalization

  Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

• Complications during hospitalization.

  Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paracetamol DRUG

Also known as: Perfalgan

Paracetamol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka Medical Center, Ben Gurion University of the Negev

Beersheba, Israel

Location

Related Publications (1)

• 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.

  PMID: 36161276 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

IL (1)