ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01460667
Previous Study | Return to List | Next Study

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
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Christina Lee, McLaren Regional Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: IV acetaminophen Drug: IV normal saline Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. difference in post-operative opiate consumption (PCA) [ Time Frame: hourly, 30 hours from first dose of study agent ]

Secondary Outcome Measures :
  1. post-operative subjective pain intensity [ Time Frame: every 2 hours, 30 hours from first dose of study agent ]
  2. post-operative nausea and vomiting (PONV) [ Time Frame: every 2 hours, 30 hours from first dose of study agent ]
  3. time to first post-operative drug administration [ Time Frame: up to 30 hours from first dose of study agent ]
  4. time to return to flatus [ Time Frame: up to 30 hours from first dose of study agent ]
  5. acceptance of rescue medication [ Time Frame: up to 30 hours from first dose of study agent ]
  6. time to first request for rescue medication [ Time Frame: up to 30 hours from first dose of study agent ]
  7. readiness for discharge [ Time Frame: up to 72 hours from the first dose of study agent ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Christina Lee, B.Sc. 517-505-4640 leechr28@msu.edu

Locations
United States, Michigan
McLaren Regional Medical Center Recruiting
Flint, Michigan, United States, 48532
Contact: Christina Lee, B.Sc.    517-505-4640    leechr28@msu.edu   
Sub-Investigator: Christina Lee, B.Sc.         
Principal Investigator: Michael Kia, D.O.         
Sponsors and Collaborators
McLaren Regional Medical Center
Mallinckrodt
Investigators
Study Director: Christina Lee, B.Sc. McLaren Regional Medical Center

Publications of Results:
Other Publications:
Responsible Party: Christina Lee, Study Coordinator, McLaren Regional Medical Center, McLaren Regional Medical Center
ClinicalTrials.gov Identifier: NCT01460667     History of Changes
Other Study ID Numbers: IV APAP LRYGBP Study
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Christina Lee, McLaren Regional Medical Center:
Laparoscopic Roux-en-Y Gastric Bypass
Post-Operative Pain
IV Acetaminophen
Post-Operative Nausea and Vomiting

Additional relevant MeSH terms:
Pain, Postoperative
Obesity, Morbid
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics