The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection

Ankara University

Status: Completed

Conditions: Back Pain; Chronic Postoperative Pain; Chest Pain

Treatments: Drug: thoracic interlaminar epidural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06507995

i7-487-21

Details and patient eligibility

About

The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.

Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.

Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.

The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey

Enrollment: 100 patients

Sex: All

Ages: 18 to 86 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 18 years old
• > 6 months pain duration
• Failed conservative management (including medication, physical therapy, and exercise programs)
• Facet joint pain ruled out (confirmed through diagnostic blocks)

Exclusion criteria

• < 18 years old
• Having a psychological illness
• Allergies to local anesthetics or steroids
• Thoracic facet joint pain
• Significant disc herniation
• Infection ( which were ruled out by pre-procedure blood tests and C-reactive protein levels)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Local Group

Other group

Description:

Group I received thoracic interlaminar epidural injections of 6 mL of 2% preservative-free prilocaine.

Treatment:

Drug: thoracic interlaminar epidural injection

Local+steroid Group

Other group

Description:

Group II received injections of 4 mL of 2% preservative-free prilocaine combined with 2 mL or 8 mg of dexamethasone, totaling 6 mL

Treatment:

Drug: thoracic interlaminar epidural injection