Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes

NCT03543033 | Withdrawn DMC

• 1 other identifier: 2018-008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lumbar radiculopathy; corticosteroid epidural injection

Outcome Measures

Primary Outcomes (1)

• Opioid Use - conversion to oral morphine equivalents using standard table

  Following spine surgery, # of prescription opioid pills used will be recorded and converted to oral morphine equivalents using a standard table. Information collected will include # of pills taken, # of prescription refills, and respective dates.

  Primary endpoint is 3 Months

Secondary Outcomes (3)

• Disability - Oswestry Disability Index (ODI)

  Baseline, 1 week post-op, 1 month post-op, and 3 months post-op

• Pain - Visual Analog Scale (VAS)

  Baseline, 1 week post-op, 1 month post-op, and 3 months post-op

• Quality of Life - EuroQol-5D

  Baseline, 1 week post-op, 1 month post-op, and 3 months post-op

Other Outcomes (1)

• Cost Analysis - Health Resource Diary

  1 week post-op, 1 month post-op, 3 months post-op

Study Arms (2)

Treatment

EXPERIMENTAL

Patients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery

Drug: Corticosteroid injection

Control

NO INTERVENTION

Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery.

Interventions

Corticosteroid injection DRUG

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

Treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 30-75 years of age
• Patients diagnosed with diagnoses with single level unilateral lumbar radiculopathy
• Patients diagnosed with spinal stenosis or disc herniation
• Patients who have a history of \> 6 weeks of at least 1 conservative treatment
• ASA \< III

You may not qualify if:

• Patients who have undergone previous lumbar spinal surgery at index level
• Patients diagnosed with spondylolisthesis at index level
• Patients currently taking anti-coagulant therapy
• Active treatment of major psychiatric condition such as major depression and/or anxiety disorder.
• Patients currently seeking or receiving workers compensation
• Patients who have undergone previous corticosteroid injection at index level
• Morbid obesity defined as BMI \> 40
• Patients with history of chronic opioid use
• Patients with a contrast dye allergy
• Extruded disc fragment

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803, United States

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Erica J Bial, M.D., M.S.

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

• Robert G Whitmore, M.D.

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial with randomization ratio 1:1

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: June 1, 2018
• Study Start: September 10, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)