Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients

NCT01460667 | Unknown DMC

• 1 other identifier: IV APAP LRYGBP Study
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Laparoscopic Roux-en-Y Gastric Bypass; Post-Operative Pain; IV Acetaminophen; Post-Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• difference in post-operative opiate consumption (PCA)

  hourly, 30 hours from first dose of study agent

Secondary Outcomes (7)

• post-operative subjective pain intensity

  every 2 hours, 30 hours from first dose of study agent

• post-operative nausea and vomiting (PONV)

  every 2 hours, 30 hours from first dose of study agent

• time to first post-operative drug administration

  up to 30 hours from first dose of study agent

• time to return to flatus

  up to 30 hours from first dose of study agent

• acceptance of rescue medication

  up to 30 hours from first dose of study agent

Study Arms (2)

IV acetaminophen

ACTIVE COMPARATOR

Drug: IV acetaminophen

IV 0.9% normal saline

PLACEBO COMPARATOR

Drug: IV normal saline

Interventions

IV acetaminophen DRUG

IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours

IV acetaminophen

IV normal saline DRUG

0.9% normal saline IV, every 6 hours over 30 hours.

IV 0.9% normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• McLaren Regional Medical Center: lead
• Cadence Pharmaceuticals: collaborator

Study Sites (1)

McLaren Regional Medical Center

Flint, Michigan, 48532, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 10945358 BACKGROUND

• 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.

  PMID: 11472277 RESULT

• 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.

  PMID: 21114616 RESULT

• 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.

  PMID: 21353105 RESULT

• 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.

  PMID: 15978146 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative; Vomiting

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christina Lee, B.Sc.

  McLaren Regional Medical Center

  STUDY DIRECTOR

Central Study Contacts

Christina Lee, B.Sc.

CONTACT

517-505-4640; leechr28@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator, McLaren Regional Medical Center

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

US (1)