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

Soroka University Medical Center220 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Obesity

Interventions

ParacetamolDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Soroka Medical Center, Ben Gurion University of the Negev

Beersheba, Israel

Outcomes

Primary Outcomes

amount of morphine

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 Outcomes

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 frame: 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)

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)

Complications during hospitalization.

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)

Data from ClinicalTrials.gov

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