Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade (PLAN)

University of Aarhus

Status: Enrolling

Conditions: Foraminal Stenosis; Stenosis, Spinal; Radiculopathy Lumbar; Herniated Disc; Radiculopathy Sacral

Treatments: Diagnostic Test: Selective nerve root block (SNRB)

Study type: Interventional

Funder types: Other

Identifiers

NCT06143813

PLAN

Details and patient eligibility

About

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.

Full 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)

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years old
• Suspected lumbar radiculopathy persistent ≥ 8 weeks
• Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)

Exclusion criteria

• Prior lumbar spine surgery
• Mental illness
• Language barrier in Danish
• Severe physical co-morbidity
• Known allergies to medicine used in the study
• Pregnant
• Plans to move abroad during the next 12-months

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Block

Active Comparator group

Description:

This group will receive standard of care + a selective nerve root block as part of the diagnostic work up.

Treatment:

Diagnostic Test: Selective nerve root block (SNRB)

No-block

No Intervention group

Description:

This group will receive standard of care.