Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Primary Purpose
Joint Pain
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Retrolaminar block
Medial Branch Block
Sponsored by
About this trial
This is an interventional treatment trial for Joint Pain
Eligibility Criteria
Inclusion Criteria:
- Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments
- numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- Body mass index ˂ 30
Exclusion Criteria:
- The exclusion criteria are patient refusal
- local or systemic sepsis, coagulopathy,
- unstable cardiovascular and respiratory diseases,
- previous neurological deficits,
- history of psychiatric disorders,
- history of drug abuse,
- distorted local anatomy,
- those who were allergic to the used medications .
Sites / Locations
- Yahya WahbaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group medial branch block
Group retrolaminar block
Arm Description
cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
Outcomes
Primary Outcome Measures
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Numerical rating score
from zero to 10 (where 0 no pain, 10 the worst pain)
Secondary Outcome Measures
Neck disability index
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Neck disability index
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05184881
Brief Title
Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Official Title
Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cervical facet joints have been implicated as a source of chronic pain in 54-67 % patients with chronic posterior neck pain.1 Intraarticular injections, medial branch nerve blocks and neurolysis of medial branch nerves have been described in managing chronic neck pain of facet joint origin.2 The evidence for long-term therapeutic benefits of intraarticular injections of facet joints is limited. Medial branch nerve blocks show moderate evidence of long-term benefit with evidence of side effects.3 Paraneuraxial nerve blocks have become very popular clinically, due to their clinical and anatomical characteristics. These techniques are comparable to neuraxial nerve blocks in terms of success rate and analgesic efficacy and may confer many of advantages over neuraxial nerve blocks.4 Retrolaminar blocks are among this family that are near but not within the neuraxis like spinals or epidurals.5 Most reports and studies of retrolaminar blocks have been in the context of anesthesia for truncal surgery and truncal pain syndromes (thoracic and abdominal).6 Postoperative and pain treatment cervical retrolaminar blocks studies are currently sparse.7 The major advantage of this technique is minimizing or even eliminating the risk of pneumothorax. Additionally, the risks of nerve root damage and inadvertent injection into a dural sleeve, an intervertebral foramen, or the epidural or intrathecal spaces should also be decreased.8
Detailed Description
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.
The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.
Grouping:
Group M: cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
Group R: cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group medial branch block
Arm Type
Active Comparator
Arm Description
cervical medial branch block will done at the affected dermatomal level using 1 mL of a mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml).
Arm Title
Group retrolaminar block
Arm Type
Active Comparator
Arm Description
cervical retrolaminar block was done using 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) for each affected dermatomal level.
Intervention Type
Other
Intervention Name(s)
Retrolaminar block
Intervention Description
2- Cervical retrolaminar block: will be performed on prone-positioned patients. Under fluoroscopic visualization, after identification of the lamina at the desired level, a 25-gauge, 3.5-inch spinal needle was introduced and when the needle tip will be confirmed at the posterior aspect of the cervical lamina corresponding to cervical facet arthropathy level. 5 mL of a mixture of 3 mL 1% lidocaine and 2 mL dexamethasome (8mg/2ml) will be injected.
Intervention Type
Other
Intervention Name(s)
Medial Branch Block
Intervention Description
1- Cervical medial branch block: will be performed on prone-positioned patients using a posterior approach. Under fluoroscopic visualization, after identification of the waists of the articular pillars at the desired levels, each medial branch block was administered with a 25-gauge, 3.5-inch spinal needle. When the place of the needle tip will be confirmed at the mid-point of the waists of articular pillars, 1 ml of the mixture of 0.5 mL 1% lidocaine and 0.5 mL dexamethasome (8mg/2ml) will be injected at each level.
Primary Outcome Measure Information:
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
before injection
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 2 weeks from injection
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 2 month from block
Title
Numerical rating score
Description
from zero to 10 (where 0 no pain, 10 the worst pain)
Time Frame
after 3 month from block
Secondary Outcome Measure Information:
Title
Neck disability index
Description
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Time Frame
before injection
Title
Neck disability index
Description
Each of the 10 items scores from 0 to 5. The maximum score is 50. 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe and above 34 = complete.
Time Frame
after 2 weeks from injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients more than 18 years old of both genders with cervical facet joint arthropathy confirmed by magnetic resonance imaging (MRI) and neck manual examination and not responding to conservative treatments
numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
American society of Anesthesiology Physical Status class I and II,
Body mass index ˂ 30
Exclusion Criteria:
The exclusion criteria are patient refusal
local or systemic sepsis, coagulopathy,
unstable cardiovascular and respiratory diseases,
previous neurological deficits,
history of psychiatric disorders,
history of drug abuse,
distorted local anatomy,
those who were allergic to the used medications .
Facility Information:
Facility Name
Yahya Wahba
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahya m wahba, assist prof.
Phone
01211313554
Email
yahyawahba@gmail.com
First Name & Middle Initial & Last Name & Degree
adel abdel ghaffar, pof.
Phone
01210101001
Email
adelghaffar49@gmail.com
First Name & Middle Initial & Last Name & Degree
Basem I Awad, assist prof
12. IPD Sharing Statement
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Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy
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