Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?

Study Overview
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Brief Summary
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This study was aimed to investigate the impact of using different epidural volumes. Patients with acute discogenic pain were included in the study.

Detailed Description
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Objectives: This study was aimed to investigate the impact of using different epidural volumes. Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone [80 mg] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) [O= no pain, 10 = unbearable pain], SLET(straight leg elevation test) [0° = worst, 85° = best], and Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients] before and 2 weeks after the EPSI.

Official Title
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Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Epidural Volume
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute discogenic pain with less than three months duration not responding to other modalities of conservative management [NSAIDs, physiotherapy, bracing, etc.], radiological disc bulging accompanying unilateral root impingement symptoms, an Oswestry daily activity score more than 20 percent, and resistance to treatment. Exclusion Criteria: Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Volume 10mL<br>Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg | Drug: Triamcinolone<br>* Triamcinolone<br>* Other names: Kelanocort;Drug: Epidural Volume<br>* Epidural Volume<br>Drug: Bupivacaine<br>* Bupivacaine<br>* Other names: Marcaine;|
| Experimental: Epidural Volume 15mL<br>Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg | Drug: Triamcinolone<br>* Triamcinolone<br>* Other names: Kelanocort;Drug: Epidural Volume<br>* Epidural Volume<br>Drug: Bupivacaine<br>* Bupivacaine<br>* Other names: Marcaine;|
| Experimental: Epidural Volume 20mL<br>Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg | Drug: Triamcinolone<br>* Triamcinolone<br>* Other names: Kelanocort;Drug: Epidural Volume<br>* Epidural Volume<br>Drug: Bupivacaine<br>* Bupivacaine<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visual analog scale) [O= no pain, 10 = unbearable pain] |  | 2 weeks | 
| SLET(straight leg elevation test) [0° = worst, 85° = best] |  | 2 weeks | 
| Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients] |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Adverse Effect, Spinal, Epidural