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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: November 13, 2015
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:
  • Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]
    The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)


Secondary Outcome Measures:
  • Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]
    The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)

  • Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. [ Time Frame: 24 hours after baseline ] [ Designated as safety issue: No ]
    The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.


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 Sodium Chloride 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 Sodium Chloride (NaCl)

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
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

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
Results First Received: March 17, 2015
Last Updated: November 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
Pain Management

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on September 27, 2016