Clinical trial NCT02154464: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Morphine-sparing
Paracetamol
Obesity
Gastric banding
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: amount of morphine
timeFrame: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Secondary outcomes:
measure: Complication during treatment of patient in PACU:
timeFrame: Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
measure: Time discharging from PACU
timeFrame: Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
measure: Length of hospitalization
timeFrame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
measure: Complications during hospitalization.
timeFrame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center, Ben Gurion University of the Negev
Study officials:
References:
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.