Clinical Trials Directory

Trials / Completed

CompletedNCT05184881

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRetrolaminar block2- 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.
OTHERMedial Branch Block1- 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.

Timeline

Start date
2021-12-01
Primary completion
2022-08-30
Completion
2022-12-30
First posted
2022-01-11
Last updated
2024-03-04

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05184881. Inclusion in this directory is not an endorsement.