Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy

Joint Pain Clinical Trial

Official title:

Comparison Between Retrolaminar and Medial Branch Block in Cervical Facet Joint Arthropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184881
• Other study ID #: R.21.11.1534
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Joint Pain

Intervention

Other:
• Retrolaminar block
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.
• Medial Branch Block
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.

Locations

Country	Name	City	State
Egypt	Yahya Wahba	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating score	from zero to 10 (where 0 no pain, 10 the worst pain)	before injection
Primary	Numerical rating score	from zero to 10 (where 0 no pain, 10 the worst pain)	after 2 weeks from injection
Primary	Numerical rating score	from zero to 10 (where 0 no pain, 10 the worst pain)	after 2 month from block
Primary	Numerical rating score	from zero to 10 (where 0 no pain, 10 the worst pain)	after 3 month from block
Secondary	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.	before injection
Secondary	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.	after 2 weeks from injection