Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy

NCT ID: NCT02067442

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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oral acetaminophen

Patients in this arm of the study will receive oral acetaminophen and an IV placebo

Group Type ACTIVE_COMPARATOR

oral acetaminophen

Intervention Type DRUG

1000 milligrams given orally before surgery

intravenous acetaminophen

Patients in this arm of the study will receive IV acetaminophen and an oral placebo

Group Type ACTIVE_COMPARATOR

intravenous acetaminophen

Intervention Type DRUG

1000 milligrams of intravenous acetaminophen given before surgery

Interventions

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oral acetaminophen

1000 milligrams given orally before surgery

Intervention Type DRUG

intravenous acetaminophen

1000 milligrams of intravenous acetaminophen given before surgery

Intervention Type DRUG

Other Intervention Names

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Tylenol Ofirmev

Eligibility Criteria

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Inclusion Criteria

* Single level lumbar micro disk surgery
* Ages 18-65

Exclusion Criteria

* morbid obesity
* prior back surgery
* opioid tolerance
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marc D Fisicaro, MD

Role: CONTACT

215-955-6161

Facility Contacts

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Marc Fisicaro, MD

Role: primary

Other Identifiers

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12D.685

Identifier Type: -

Identifier Source: org_study_id

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