Epidural Study of Patients With Chronic Lower Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Bupivacaine; Drug: Depo-Medrol

• Registration Number: NCT00887003
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.

Detailed Description

To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Status Verified: 2011-07
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• 18-75 years old
• lower back pains > 6 months
• no lumbar epidural in past 6 months
• no previous back surgery
• written informed consent to participate in study

Exclusion Criteria

• acute lower back pain
• pregnancy
• significant psychiatric disease
• local or systemic infection
• coagulopathy/anticoagulant therapy
• bleeding diathesis
• presently enrolled in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HV/HD 4	Bupivacaine	High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
HV/HD 4	Depo-Medrol	High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
LV/LD 1	Bupivacaine	Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
LV/HD 2	Depo-Medrol	Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
LV/LD 1	Depo-Medrol	Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
LV/HD 2	Bupivacaine	Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
HV/LD 3	Bupivacaine	High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
HV/LD 3	Depo-Medrol	High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol

Primary Outcome Measures

Name	Time	Method
The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.	Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.	Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada