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NOT YET RECRUITING
NCT07813988
PHASE4

Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain

Sponsor: Benha University

View on ClinicalTrials.gov

Summary

This study will compare three fluoroscopy-guided epidural steroid injection approaches for adults with unilateral lumbosacral radicular pain caused by lumbar disc herniation. The study will evaluate whether the pattern of contrast spread in the epidural space predicts meaningful pain relief. Ninety-nine participants will be randomly assigned in equal numbers to receive one of three treatments: high-volume parasagittal interlaminar injection, low-volume parasagittal interlaminar injection, or transforaminal epidural steroid injection. Participants will not be told which injection approach they receive. Pain and disability will be assessed before treatment and at 2 weeks, 1 month, 3 months, and 6 months after injection. The main outcome is the proportion of participants with clinically meaningful improvement in pain at 3 months.

Official title: Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2026-11

Completion Date

2028-02

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

PROCEDURE

High-Volume Parasagittal Interlaminar Epidural Steroid Injection

Fluoroscopy-guided parasagittal interlaminar epidural steroid injection on the symptomatic side. After a standardized 2 mL non-ionic iodinated contrast injection, 10 mL therapeutic injectate is administered: betamethasone 24 mg and bupivacaine 0.5% 20 mg.

PROCEDURE

Low-Volume Parasagittal Interlaminar Epidural Steroid Injection

Fluoroscopy-guided parasagittal interlaminar epidural steroid injection on the symptomatic side. After a standardized 2 mL non-ionic iodinated contrast injection, 7 mL therapeutic injectate is administered: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.

PROCEDURE

Transforaminal epidural steroid injection

Fluoroscopy-guided transforaminal epidural steroid injection at the symptomatic level and side. After a standardized 2 mL non-ionic iodinated contrast injection, 3 mL therapeutic injectate is administered: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.

DRUG

Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Administered in volume-proportional doses: 24 mg in High-Volume PIL, 16.8 mg in Low-Volume PIL, and 7.2 mg in TFESI.

DRUG

Bupivacaine

Bupivacaine 0.5% is administered in volume-proportional doses: 20 mg in High-Volume PIL, 14 mg in Low-Volume PIL, and 6 mg in TFESI.

Locations (1)

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt