NCT06143813

Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention.

Detailed description

The study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic SNRB to surgical decision-making. Stratification will be based on the study site. Block size will be 4, 6, or 8 and in random order. All patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. Patients will be randomized to either standard care or SNRB after the consultation. Results of the SNRB will be available to the surgeon before deciding finally whether to operate or not. Hence, the intervention adds the outcome of the diagnostic SNRB to the shared surgical decision-making. Study outline: Baseline: Demographics, Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 1-month follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 3-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded 12-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded Randomization: Using RedCap patients will be randomized to receive a SNRB as part of the pre-operative workup or to direct operation. SNRB-procedure: At Aarhus University, the SNRB will be performed using CT-guidance; at Private Hospital Moelholm, the SNRB procedure will be guided by fluoroscopy. Drugs used are omnipaque (0,2 ml), betamethasone (0,5 ml) and bupivacain (0,5 ml)

Conditions

• Radiculopathy Lumbar
• Radiculopathy Sacral
• Herniated Disc
• Foraminal Stenosis
• Stenosis, Spinal

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Selective nerve root block (SNRB)	CT/Fluoroscopy guided nerve root block

Timeline

• Start date: 2023-11-09
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2023-11-22
• Last updated: 2024-05-02

Locations

1 site across 1 country: Denmark