Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients
NCT01460667 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2011-10-27
Summary
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.
Conditions
- Morbid Obesity
Interventions
- DRUG
-
IV normal saline
0.9% normal saline IV, every 6 hours over 30 hours.
- DRUG
-
IV acetaminophen
IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
Sponsors & Collaborators
-
Cadence Pharmaceuticals
collaborator INDUSTRY -
McLaren Regional Medical Center
lead OTHER
Principal Investigators
-
Christina Lee, B.Sc. · McLaren Regional Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2012-10-31
Countries
- United States
Study Locations
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