Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2023-02-03

Brief Summary

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Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.

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Detailed Description

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Conditions

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Lumbar; Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravenous Acetaminophen

Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.

Intravenous Placebo

Intravenous normal saline will be administered within 30 minutes of skin closure.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will received 1000mg of normal saline within 30 minutes of skin closure.

Interventions

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Acetaminophen

Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.

Intervention Type DRUG

Placebo

Patients will received 1000mg of normal saline within 30 minutes of skin closure.

Intervention Type DRUG

Other Intervention Names

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Tylenol Normal Saline

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing 1-2 levels primary spine surgery ≥18 years old

Exclusion Criteria

* Chronic opiate users
* More than 3 levels or revision spine surgery
* Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
* Allergy/hypersensitivity to acetaminophen
* Patients that have used acetaminophen during the 24 hours before their scheduled surgery

Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No