Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480175
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of Cervical Spondylosis Pain
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Comparative Study Between Cervical Medial Branch Radiofrequency Ablation Versus Radiofrequency Plus Superficial Cervical Plexus Block in Treatment of the Cervical Facet and Cervical Spondylosis Pain
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to compare the effectiveness in the pain relief between doing radiofrequency ablation for the medial branch of the cervical facet pain alone vs using it combined with superficial cervical plexus blockin adults patients with cervical spondylosis pain
The main question it aims to answer is
does adding superficial cervical plexus block to radiofrequency in patients with chronic neck pain provide better analgesia than radioprequency alone
The main question it aims to answer is
does adding superficial cervical plexus block to radiofrequency in patients with chronic neck pain provide better analgesia than radioprequency alone
Detailed Description:
participants will be placed in prone position with neck preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radiofrequency machine will be placed on the back the Neurotherm NT1100 regenerator will be used All the patients will be monitored by ECG noninvasive blood pressure and pulse oximetry
The entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2 followed by the insertion of the radiofrequency cannula STRYKER 20 G 9 cm with 1 cm active tip targeting the medial branches supplying C4 C5 C6 C7 bilateral
the investigators will use 1 entry site for each side and then redirect the needles
Confirmation of the appropriate location will be done on fluoroscopy in both A-P and lateral views Once targeted sensory stimulation will be done and every patient is asked if he feels the same pain as that he used to suffer from Once confirmed with absence of motor response 1 more ml of lidocaine 20 is injected and then start our ablation for 180 sec at 80 degrees
The procedure will be done bilateral the same After 2 weeks patient will be readmitted and then the investigators will choose to inject the superficial cervical plexus with 5 ml of lidocaine 20 plus 40 mg triamcinolone injection was random in the right or left side using ultrasound to confirm success
The side of the block will be recorded for each patient either right or left Comparison will be done between both sides to study the effect of adding superficial plexus block to radio-frequency whether the analgesic effect is better on the side of radio frequency alone or the side where the superficial cervical plexus block was added to radio-frequency
The patients will then be asked to be followed up after 1 month and after 6 months and about the improvement in the numeric pain score NPS and the patient global impression of change PGIC and if they feel that one side is better than the other or they feel the same Visual analogue score scale will be recorded for documentation
The entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2 followed by the insertion of the radiofrequency cannula STRYKER 20 G 9 cm with 1 cm active tip targeting the medial branches supplying C4 C5 C6 C7 bilateral
the investigators will use 1 entry site for each side and then redirect the needles
Confirmation of the appropriate location will be done on fluoroscopy in both A-P and lateral views Once targeted sensory stimulation will be done and every patient is asked if he feels the same pain as that he used to suffer from Once confirmed with absence of motor response 1 more ml of lidocaine 20 is injected and then start our ablation for 180 sec at 80 degrees
The procedure will be done bilateral the same After 2 weeks patient will be readmitted and then the investigators will choose to inject the superficial cervical plexus with 5 ml of lidocaine 20 plus 40 mg triamcinolone injection was random in the right or left side using ultrasound to confirm success
The side of the block will be recorded for each patient either right or left Comparison will be done between both sides to study the effect of adding superficial plexus block to radio-frequency whether the analgesic effect is better on the side of radio frequency alone or the side where the superficial cervical plexus block was added to radio-frequency
The patients will then be asked to be followed up after 1 month and after 6 months and about the improvement in the numeric pain score NPS and the patient global impression of change PGIC and if they feel that one side is better than the other or they feel the same Visual analogue score scale will be recorded for documentation
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?:
False
Is an FDA AA801 Violation?:
None