Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

NCT01527942 | Terminated Results DMC

• 1 other identifier: 12-01-003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Pain

Keywords

Pain Management

Outcome Measures

Primary Outcomes (1)

• Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours

  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)

  baseline and 24 hours

Secondary Outcomes (2)

• Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours

  baseline and 24 hours

• 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.

  24 hours after baseline

Study Arms (2)

Arm 1 - Active Drug

EXPERIMENTAL

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

Arm 2 - Placebo

PLACEBO COMPARATOR

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

Interventions

Acetaminophen DRUG

Intravenous Acetaminophen 1,000 mg IV

Also known as: OFIRMEV

Arm 1 - Active Drug

Placebo DRUG

Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)

Arm 2 - Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• know hypersensitivity to acetaminophen or opioids
• impairment in liver function
• renal dysfunction
• mental retardation

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (1)

Saint Francis Hospital

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Obesity; Pain; Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Ioannis Raftopoulos, MD
• Organization: ST. FRANCIS HOSPITAL AND MEDICAL CENTER

IRaftopo@stfranciscare.org

Study Officials

• Ioannis Raftopoulos, MD

  Saint Francis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2014-03

Locations

US (1)