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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460667 on ClinicalTrials.gov