NCT00887003

Epidural Study of Patients With Chronic Lower Back Pain

Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine	Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
DRUG	Bupivacaine	Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
DRUG	Bupivacaine	High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
DRUG	Bupivacaine	High Volume, High Dose (10cc, 10mg plain Bupivacaine)
DRUG	Depo-Medrol	80mg Depo-Medrol

Timeline

• Start date: 2005-05-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2009-04-23
• Last updated: 2012-02-08

Locations

1 site across 1 country: Canada