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

June 2, 2014 updated by: Alexander Zlotnik, Soroka University Medical Center
The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka Medical Center, Ben Gurion University of the Negev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Paracetamol
Drug: Paracetamol
Other Names:
  • Perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of morphine
Time Frame: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication during treatment of patient in PACU:
Time Frame: Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)

Complication during treatment of patient in PACU, including:

  • Respiratory complications (respiratory support, need for ICU, etc)
  • Cardiovascular complications (hemodynamic instability, inotropic support )
  • Gastrointestinal complications (nausea and vomiting tested by PONV scale, need to use antiemetic drugs)
  • Incidence of urinary retention and need for catheterization
  • Pruritus
Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Time discharging from PACU
Time Frame: Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Length of hospitalization
Time Frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Complications during hospitalization.
Time Frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

Complications during hospitalization, including :

  • Septic complications
  • Respiratory, cardiac or other complications
Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR 0024-14 CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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