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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Morphine-sparing, Paracetamol, Obesity, Gastric banding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Soroka Medical Center, Ben Gurion University of the Negev

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paracetamol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complication during treatment of patient in PACU:
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
Time discharging from PACU
Length of hospitalization
Complications during hospitalization.
Complications during hospitalization, including : Septic complications Respiratory, cardiac or other complications

Full Information

First Posted
May 26, 2014
Last Updated
June 2, 2014
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02154464
Brief Title
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
Official Title
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Morphine-sparing, Paracetamol, Obesity, Gastric banding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
amount of morphine
Description
The primary outcome will be the comparison amount of morphine injected in each group until discharge
Time Frame
Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Secondary Outcome Measure Information:
Title
Complication during treatment of patient in PACU:
Description
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
Time Frame
Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Title
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)
Title
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)
Title
Complications during hospitalization.
Description
Complications during hospitalization, including : Septic complications Respiratory, cardiac or other complications
Time Frame
Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Soroka Medical Center, Ben Gurion University of the Negev
City
Beer Sheva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Zlotnik, M.D. Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
36161276
Citation
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.
Results Reference
derived

Learn more about this trial

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

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