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Super-voltage PRF of Stellate Ganglion Versus Super-voltage PRF of T2 T3 Sympathetic Ganglia in Managing PMPS.

NCT07675096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-06-30

No results posted yet for this study

Summary

The aim of this study is to compare the effectiveness of super-voltage pulsed radiofrequency of stellate ganglion and super-voltage pulsed radiofrequency of T2-T3 sympathetic ganglia in the treatment of postmastectomy pain syndrome.

Conditions

  • Post Mastectomy Pain Syndrome
  • Chronic Pain Following Surgical Procedure for Cancer

Interventions

PROCEDURE

Group S : Stellate Ganglion supervoltage pulsed radiofrequency

· Super-voltage pulsed radiofrequency (PRF) of the stellate ganglion was performed under strict aseptic precautions with standard monitoring. Patients were positioned supine with a slight extension of the neck and head turned contralaterally. Ultrasound guidance using a high-frequency linear transducer was employed to identify the stellate ganglion region at the level of the C6 transverse process, anterior to the longus colli muscle and medial to the carotid sheath. A 22-gauge radiofrequency cannula (5-10 cm length, 5-mm active tip) was advanced using an in-plane technique until the needle tip was positioned adjacent to the sympathetic chain on the surface of the longus colli muscle. After negative aspiration, sensory (50 Hz) and motor (2 Hz) stimulation were performed to confirm appropriate needle placement and exclude somatic nerve involvement. Pulsed radiofrequency was then delivered using a supervoltage protocol with a pulse width of 20 ms at a frequency of 2 Hz, applied

PROCEDURE

Group T : T2-T3 chains supervoltage pulsed radiofrequency.

Position the patient prone with bolsters to minimize lordosis and allow C- arm AP and oblique imaging. Under sterile conditions use fluoroscopy to identify T2 and T3 pedicles, ribs and transverse processes. A posterior paravertebral (transforaminal-style) approach is commonly used: advance a curved RFA cannula (20-22G, 10-15 cm with 5-10 mm active tip) under fluoroscopic AP and lateral guidance to the anterolateral aspect of the vertebral body or just anterior to the costotransverse junction at the T2 and T3 levels, the expected location of the thoracic sympathetic chain. Confirm needle position with small (0.5-1 mL) contrast injection to exclude intravascular or pleural spread. Perform sensory (50 Hz) and, if applicable, motor (2 Hz) stimulation to exclude intercostal motor/pleural/nerve root proximity. For supervoltage PRF, deliver radiofrequency with pulse width 20ms at 2 Hz while maintain the electrode tip temperatue less than 42°C for 120-240 seconds at each level

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-30
Completion
2027-08-30

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 NCT07675096 on ClinicalTrials.gov