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

Not Applicable

• Conditions: Obesity
• Interventions: Drug: Paracetamol; Drug: Placebo

• Registration Number: NCT02154464
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Status Verified: 2014-05
• Study First Submitted: 2014-05-26
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-02
• Last Update Submitted: 2014-06-02
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	Paracetamol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
amount of morphine	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

Secondary Outcome Measures

Name	Time	Method
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)	Complications during hospitalization, including : * Septic complications; * Respiratory, cardiac or other complications
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)	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	Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)

Trial Locations

Locations (1)

Soroka Medical Center, Ben Gurion University of the Negev; 🇮🇱 Beer Sheva, Israel