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Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome

NCT06033456 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-10-10

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).

Conditions

  • Stellate Ganglion
  • Radiofrequency Ablation
  • Complex Regional Pain Syndromes
  • Mastectomy

Interventions

PROCEDURE

Radiofrequency stellate ganglion block using ultrasound guidance (SGB)

Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8). Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning

PROCEDURE

Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)

Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.

PROCEDURE

Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block

Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-07
Primary Completion
2024-03-15
Completion
2024-03-15

Countries

  • Egypt

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 NCT06033456 on ClinicalTrials.gov