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

NCT05184881 | Completed Phase 2

• 1 other identifier: R.21.11.1534
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Joint Pain

Outcome Measures

Primary Outcomes (4)

• Numerical rating score

  from zero to 10 (where 0 no pain, 10 the worst pain)

  before injection

• Numerical rating score

  from zero to 10 (where 0 no pain, 10 the worst pain)

  after 2 weeks from injection

• Numerical rating score

  from zero to 10 (where 0 no pain, 10 the worst pain)

  after 2 month from block

• Numerical rating score

  from zero to 10 (where 0 no pain, 10 the worst pain)

  after 3 month from block

Secondary Outcomes (2)

• Neck disability index

  before injection

• Neck disability index

  after 2 weeks from injection

Study Arms (2)

Group medial branch block

ACTIVE COMPARATOR

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).

Other: Medial Branch Block

Group retrolaminar block

ACTIVE COMPARATOR

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.

Other: Retrolaminar block

Interventions

Retrolaminar block OTHER

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.

Group retrolaminar block

Medial Branch Block OTHER

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.

Group medial branch block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Yahya Wahba

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. of anesthesia and pain management

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: December 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

EG (1)