A clinical trial to study the convenience of ultrasound versus fluoroscopy guided caudal epidural block for low back pain with radiculopathy

Phase 4

Recruiting

Conditions: Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,

Brief Summary: This study is a randomised, prospective,open labled trial. This study is planned to compare the efficacy and adverse effects of USG guidedversus fluoroscopy guided caudal epidural block for LBP with radiculopathy. the aim of this study id to compare the analgesic efficacy of ultrasound versus fluoroscopy guided caudal epiduralblock for low back pain with radiculopathy. The primary objective is to compare the correct time of epidural needle placement, with secondary objective of reduction of pain score by 0-10 Numeric Rating Scale (NRS),reduction of ODI and occurrence of adverse events if any at the end of 2nd, 4th, 8th, 12th week.

Recruitment & Eligibility

Inclusion Criteria

Patients attending the Pain Clinic of the Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, with chronic low back pain (LBP) of more than 3 months duration with bilateral radiculopathy, not responding to conservative treatment 2) Age 25- 80 years 3) American Society of Anaesthesiology (ASA)Physical status I or II 4) Magnetic resonance imaging (MRI) of lumbosacral spine findings of disc protrusion and disc bulge at various levels of lumbar spine and impingement of exiting and traversing nerve roots.

Exclusion Criteria

Patients refusing to provide informed consent 2) Systemic infection or local infection at the site of injection 3) Bleeding diathesis or full anticoagulation 4) Significant allergic reaction/hypersensitivity to contrast, anaesthetic, or corticosteroid 5) Local malignancy 6) Patient refusal 7) Uncontrolled diabetes mellitus 8) Patients with severe cardiovascular, respiratory, renal, and hepatic diseases 9) Pregnancy (due to fluoroscopy) 10) Cases with severe motor weakness, rapidly progressing neurological deficit, cauda equina syndrome.

Primary Outcome Measures

Name	Time	Method
Time taken for correct placement of epidural needle, measured in seconds.	2nd, 4th, 8th, 12th week.

Secondary Outcome Measures

Name	Time	Method
NRS for pain (0-10) scores and ODI values 2nd, 4th, 8th, 12th week.	2nd, 4th, 8th, 12th week.

Locations (1): Government Medical College and Hospital
🇮🇳
Chandigarh, CHANDIGARH, India
Government Medical College and Hospital
🇮🇳Chandigarh, CHANDIGARH, India
Dr Shrey goel
Principal investigator
8054383904
shrey12goel@gmail.com