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Optimal Performance of RFA of the Nerves Supplying the Posterior Sacroiliac Joint Complex.

NCT02808962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-11

No results posted yet for this study

Summary

The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5% Bupivacaine) are performed proximal to the origin of both the nerves to the SIJ and the cutaneous branches. Therefore, a technically accurate block should anesthetize not only the SIJ but also the skin of the buttock regardless of the patient symptoms. Hypoesthesia of the buttock would, therefore, be a quality-assurance sign that the block has been performed in a technically correct fashion. Similarly, if the target nerves have been accurately ablated by RFA hypoesthesia of the buttock should ensue, as an expected effect of the procedure.

Conditions

  • Osteoarthritis Nos, of Sacroiliac Joint

Interventions

PROCEDURE

Cooled RFA of sacral lateral branches

A single target will be identified at the junction of the sacral ala and S1 superior articular process, corresponding to the location of the L5 dorsal ramus. Then, utilizing a stainless steel Epsilon Ruler (Kimberly Clark, Irving, TX, USA), three targets will be localized 8-10 mm lateral to the S1 and S2 posterior sacral foramen at the 2:30, 4:00, and 5:30 positions. Two targets will be localized at the S3 level. Local infiltration with 1% lidocaine and minimal sedation with IV midazolam will be utilized. Once suitable sensory and motor stimulation are verified and impedance is acceptable, each target will be anesthetized with 1 mL of 1% lidocaine prior to each lesion being created at 60 degrees centigrade for 2 minutes and 30 seconds.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Yakov Vorobeychik · Hershey Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2022-02-04
Completion
2022-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808962 on ClinicalTrials.gov