Clinical trial NCT06143813: Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Official title: Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiculopathy Lumbar
Radiculopathy Sacral
Herniated Disc
Foraminal Stenosis
Stenosis, Spinal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Private Hospital Moelholm
First posted: 2023-11-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Minimum clinically important difference (MCID)
timeFrame: 3 months after surgery/decision not to operate
Secondary outcomes:
measure: Leg pain
timeFrame: 3 months after surgery/decision not to operate
measure: Back pain
timeFrame: 3 months after surgery/decision not to operate
measure: SF-36 (Short form 36)
timeFrame: 3 months after surgery/decision not to operate
measure: EQ5D (EuroQol 5D)
timeFrame: 3 months after surgery/decision not to operate
measure: ODI
timeFrame: 3 months after surgery/decision not to operate
measure: Subanalysis
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: David Kocemba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Mikkel Rasmussen, MD
role: STUDY_DIRECTOR
affiliation: Private Hospital Moelholm
name: Bent Uhrbrand, MD
role: STUDY_CHAIR
References: