Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143813
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-11-09
Brief Title:
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAN
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 02 ml betamethasone 05 ml and bupivacain 05 ml
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 02 ml betamethasone 05 ml and bupivacain 05 ml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None