Epidural Study of Patients With Chronic Lower Back Pain

February 7, 2012 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LV/LD 1
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Names:
  • methylprednisolone
EXPERIMENTAL: LV/HD 2
Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Names:
  • methylprednisolone
EXPERIMENTAL: HV/LD 3
High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Names:
  • methylprednisolone
EXPERIMENTAL: HV/HD 4
High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol
Drug: Bupivacaine
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Bupivacaine
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Other Names:
  • steroid
Drug: Depo-Medrol
80mg Depo-Medrol
Other Names:
  • methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 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.
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

Outcome Measure
Time Frame
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Julian Mulcaster, MD, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (ESTIMATE)

April 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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