Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients (IV APAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01460667|
Recruitment Status : Unknown
Verified October 2011 by Christina Lee, McLaren Regional Medical Center.
Recruitment status was: Recruiting
First Posted : October 27, 2011
Last Update Posted : October 27, 2011
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks.
The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Drug: IV acetaminophen Drug: IV normal saline||Not Applicable|
Opioid use during the post-operative period is a highly effective means of treatment for acute pain, however not without its adverse effects including post-operative nausea, vomiting (PONV), constipation, urinary retention, sedation and respiratory depression. Such factors have been implied in the literature to contribute to prolonged post-operative length of stay, delayed return to diet, return of bowel function and increased incidence of ileus. Alternatively, non-opioids, such as acetaminophen, aspirin, NSAIDs, and selective cyclo-oxygenase-2 inhibitors, can be utilized for acute pain, either alone or in combination with opioids. In the bariatric post-surgical population, NSAIDS both oral and IV (Toradol, Ibuprofen) are not recommended due to their potential bleeding tendency, anti-inflammatory effect, and ulcerogenic effect.
The LRYGBP may be classified as a surgery type associated with mild to moderate post-operative pain. Therefore, the mode of pain relief could directly affect the length of stay. The advent of IV acetaminophen serves as a opportunity to investigate in detail the efficacy of this non-opioid medication in the management of acute pain in the immediate post-operative period without the aforementioned adverse effects as expected from traditional opiate medications. A comprehensive approach to this study includes a prospective, double-blinded, randomized controlled trial of subjects who will undergo LRYGBP and randomized to the study agent (IV acetaminophen) or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Single Center Study of IV Acetaminophen for the Treatment of Post-Operative Pain After Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP)|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Active Comparator: IV acetaminophen||
Drug: IV acetaminophen
IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
|Placebo Comparator: IV 0.9% normal saline||
Drug: IV normal saline
0.9% normal saline IV, every 6 hours over 30 hours.
- difference in post-operative opiate consumption (PCA) [ Time Frame: hourly, 30 hours from first dose of study agent ]
- post-operative subjective pain intensity [ Time Frame: every 2 hours, 30 hours from first dose of study agent ]
- post-operative nausea and vomiting (PONV) [ Time Frame: every 2 hours, 30 hours from first dose of study agent ]
- time to first post-operative drug administration [ Time Frame: up to 30 hours from first dose of study agent ]
- time to return to flatus [ Time Frame: up to 30 hours from first dose of study agent ]
- acceptance of rescue medication [ Time Frame: up to 30 hours from first dose of study agent ]
- time to first request for rescue medication [ Time Frame: up to 30 hours from first dose of study agent ]
- readiness for discharge [ Time Frame: up to 72 hours from the first dose of study agent ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460667
|Contact: Christina Lee, B.Sc.||email@example.com|
|United States, Michigan|
|McLaren Regional Medical Center||Recruiting|
|Flint, Michigan, United States, 48532|
|Contact: Christina Lee, B.Sc. 517-505-4640 firstname.lastname@example.org|
|Sub-Investigator: Christina Lee, B.Sc.|
|Principal Investigator: Michael Kia, D.O.|
|Study Director:||Christina Lee, B.Sc.||McLaren Regional Medical Center|