Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial|
- Pain relief measured at selected intervals [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]Categorical scale will be used to meaure pain at hours 1,2,4,6 after first dose and then at hour 12, after 2nd dose and hour 18 after third dose and hour 24 after 4th dose.
- Comparison of Recovery room pain management data [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]Use of cumalative PCA and oral morphine use.
- Comparison of patient satisfaction [ Time Frame: 24 hours post-operative ] [ Designated as safety issue: No ]Assessment of patient satisfaction using 4 point scale at each time pain is evaluated post-operatively.
|Study Start Date:||March 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1 - Active Drug
Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Intravenous Acetaminophen 1,000 mg IV
Other Name: OFIRMEV
Placebo Comparator: Arm 2 - Placebo
Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo - IV administration 0.9% 100 ml NaCl
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527942
|United States, Connecticut|
|Saint Francis Hospital|
|Hartford, Connecticut, United States, 06105|
|Principal Investigator:||Ioannis Raftopoulos, MD||Saint Francis|