Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

This study has been terminated.
(Study Terminated per Principal Investigator's request)
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01527942
First received: February 2, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.


Condition Intervention
Obesity
Pain
Drug: Acetaminophen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Pain relief measured at selected intervals [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    Categorical scale will be used to meaure pain at hours 1,2,4,6 after first dose and then at hour 12, after 2nd dose and hour 18 after third dose and hour 24 after 4th dose.


Secondary Outcome Measures:
  • Comparison of Recovery room pain management data [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
    Use of cumalative PCA and oral morphine use.

  • Comparison of patient satisfaction [ Time Frame: 24 hours post-operative ] [ Designated as safety issue: No ]
    Assessment of patient satisfaction using 4 point scale at each time pain is evaluated post-operatively.


Enrollment: 34
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Active Drug
Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Drug: Acetaminophen
Intravenous Acetaminophen 1,000 mg IV
Other Name: OFIRMEV
Placebo Comparator: Arm 2 - Placebo
Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Drug: Placebo
Placebo - IV administration 0.9% 100 ml NaCl

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbidly Obese and body mass index (BMI) of 35
  • Between ages 20-17
  • Candidates for Laparoscopic Bariatric Surgery

Exclusion Criteria:

  • know hypersensitivity to acetaminophen or opioids
  • impairment in liver function
  • renal dysfunction
  • mental retardation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527942

Locations
United States, Connecticut
Saint Francis Hospital
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Ioannis Raftopoulos, MD Saint Francis
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01527942     History of Changes
Other Study ID Numbers: 12-01-003
Study First Received: February 2, 2012
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
Pain Management

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014