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Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

NCT02061774 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-05-06

Study results available
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Summary

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Conditions

  • Low Back Pain

Interventions

DRUG

Acetaminophen

1 gram of intravenous Acetaminophen

DRUG

Placebo comparator

placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Jason Felton, MD · TTUHSC department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-01-11
Completion
2018-01-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061774 on ClinicalTrials.gov