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Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes

NCT03543033 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-18

No results posted yet for this study

Summary

This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. The hypothesis of this study is that patients who receive the preoperative corticosteroid injection will have less reduced postoperative opioid use, as well as earlier mobilization, reduced length of stay, and faster return to work compared to control patients who do not receive the injection.

Conditions

  • Lumbar Radiculopathy

Interventions

DRUG

Corticosteroid injection

These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Erica J Bial, M.D., M.S. · Lahey Clinic

  • Robert G Whitmore, M.D. · Lahey Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • United States

Study Locations

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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 NCT03543033 on ClinicalTrials.gov