- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460667
Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients (IV APAP)
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Lee, B.Sc.
- Phone Number: 517-505-4640
- Email: leechr28@msu.edu
Study Locations
-
-
Michigan
-
Flint, Michigan, United States, 48532
- Recruiting
- McLaren Regional Medical Center
-
Contact:
- Christina Lee, B.Sc.
- Phone Number: 517-505-4640
- Email: leechr28@msu.edu
-
Sub-Investigator:
- Christina Lee, B.Sc.
-
Principal Investigator:
- Michael Kia, D.O.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who are scheduled to undergo laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP) under general anesthesia.
- age 18 to 65 years
- BMI >35
- ASA scores 1,2, or 3
- a negative pregnancy test for female subjects of childbearing age
- ability to read, understand and provide informed consent to the study procedures
- ability to read and understand the use of pain and nausea scales (VAS)
Exclusion Criteria:
- known hypersensitivity to acetaminophen or opioids
- use of opioid or schedule II medications prior to commencement of the study >7 days
- those with chronic pain conditions or significant medical disease requiring pain control
- abnormal liver function (aspartate aminotransferase/alanine aminotransferase/bilirubin > 3X upper limit of normal range, active hepatic disease, clinically significant liver disease, cirrhosis or hepatitis)
- known or suspected alcohol, drug or opiate abuse or dependence; or participation in other clinical study within 30 days of surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: IV acetaminophen
|
IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
|
Placebo Comparator: IV 0.9% normal saline
|
0.9% normal saline IV, every 6 hours over 30 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
difference in post-operative opiate consumption (PCA)
Time Frame: hourly, 30 hours from first dose of study agent
|
hourly, 30 hours from first dose of study agent
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
post-operative subjective pain intensity
Time Frame: every 2 hours, 30 hours from first dose of study agent
|
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
|
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
|
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
|
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
|
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
|
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
|
up to 72 hours from the first dose of study agent
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Christina Lee, B.Sc., McLaren Regional Medical Center
Publications and helpful links
General Publications
- Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28.
- Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
- Nguyen NT, Ho HS, Palmer LS, Wolfe BM. A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg. 2000 Aug;191(2):149-55; discussion 155-7. doi: 10.1016/s1072-7515(00)00276-3.
- Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.
- Madan AK, Ternovits CA, Speck KE, Tichansky DS. Inpatient pain medication requirements after laparoscopic gastric bypass. Obes Surg. 2005 Jun-Jul;15(6):778-81. doi: 10.1381/0960892054222812.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Pain, Postoperative
- Obesity, Morbid
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Acetaminophen
Other Study ID Numbers
- IV APAP LRYGBP Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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