Epidural Study of Patients With Chronic Lower Back Pain - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00887003

Purpose

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.

Condition	Intervention
Chronic Low Back Pain	Drug: Bupivacaine Drug: Depo-Medrol

MedlinePlus related topics: Anesthesia Anxiety Back Pain Depression

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Bupivacaine hydrochloride Bupivacaine Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain

Further study details as provided by McMaster University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	May 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol	Drug: Bupivacaine Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) Drug: Depo-Medrol 80mg Depo-Medrol
2: Experimental Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol	Drug: Bupivacaine Low Volume, High Dose (5cc, 10mg plain Bupivacaine) Drug: Depo-Medrol 80mg Depo-Medrol
3: Experimental High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol	Drug: Bupivacaine High Volume, Low Dose (10cc, 5mg plain Bupivacaine) Drug: Depo-Medrol 80mg Depo-Medrol
4: Experimental High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol	Drug: Bupivacaine High Volume, High Dose (10cc, 10mg plain Bupivacaine) Drug: Depo-Medrol 80mg Depo-Medrol

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887003

Contacts

Contact: Lynda Rickards, RN

905-521-2100 ext 44481

rickards@mcmaster.ca

Locations

Canada, Ontario
Hamilton General Hospital	Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Julian Mulcaster, MD
Sub-Investigator: Norman Buckley, MD

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Julian Mulcaster, MD

Hamilton Health Sciences

More Information

No publications provided

Responsible Party:	Hamilton Health Sciences ( Dr. Julian Mulcaster, MD, FRCPC )
Study ID Numbers:	04-392
Study First Received:	April 22, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00887003 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

epidural
volume
dose
pain relief
steroid

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Central Nervous System Depressants
Low Back Pain
Methylprednisolone acetate
Anesthetics
Pain
Prednisolone acetate

Hormones
Glucocorticoids
Neuroprotective Agents
Back Pain
Anesthetics, Local
Signs and Symptoms
Prednisolone
Neurologic Manifestations
Bupivacaine
Peripheral Nervous System Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Antiemetics
Prednisolone acetate
Pain
Hormones
Neuroprotective Agents
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Methylprednisolone Hemisuccinate

Antineoplastic Agents, Hormonal
Nervous System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Low Back Pain
Central Nervous System Depressants
Glucocorticoids
Protective Agents
Back Pain
Anesthetics, Local
Pharmacologic Actions
Autonomic Agents
Prednisolone
Neurologic Manifestations
Bupivacaine

ClinicalTrials.gov processed this record on May 07, 2009