Epidural Study of Patients With Chronic Lower Back Pain

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Drug: Depo-Medrol; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00887003

04-392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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252 participants in 4 patient groups

LV/LD 1

Experimental group

Description:

Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol

Treatment:

Drug: Bupivacaine

Drug: Depo-Medrol

Drug: Bupivacaine

Drug: Bupivacaine

Drug: Bupivacaine

LV/HD 2

Experimental group

Description:

Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol

Treatment:

Drug: Bupivacaine

Drug: Depo-Medrol

Drug: Bupivacaine

Drug: Bupivacaine

Drug: Bupivacaine

HV/LD 3

Experimental group

Description:

High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol

Treatment:

Drug: Bupivacaine

Drug: Depo-Medrol

Drug: Bupivacaine

Drug: Bupivacaine

Drug: Bupivacaine

HV/HD 4

Experimental group

Description:

High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol

Treatment:

Drug: Bupivacaine

Drug: Depo-Medrol

Drug: Bupivacaine

Drug: Bupivacaine

Drug: Bupivacaine