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Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

NCT ID: NCT01527942

Last Updated: 2015-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Pain

Keywords

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Intravenous Acetaminophen 1,000 mg IV

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Acetaminophen

Intravenous Acetaminophen 1,000 mg IV

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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OFIRMEV

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trinity Health Of New England

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioannis Raftopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Francis

Locations

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Saint Francis Hospital

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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12-01-003

Identifier Type: -

Identifier Source: org_study_id