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

NCT07675096 | Not Yet Recruiting DMC

• 1 other identifier: AP2604-201-224-209
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Analgesics; Opioids; gabapentin; post mastectomy pain syndrome; chronic pain; Radiofrequency; stellate ganglion block; sympathectomy; T2; T3; SV-PRF; super-voltage pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• Change in VAS score in groups

  Change in visual analogue scale score in groups at different time intervals (baseline, 1 week, 1 month, 3 months, 6 months)

  6 months

Secondary Outcomes (4)

• Change in Brief Pain Inventory in groups.

  6 months

• Patient satisfaction

  6 months

• dose reduction in antineuropathic drugs

  6 months

• procedural complications.

  6 months

Study Arms (3)

Group S: Stellate Ganglion super-voltage pulsed radiofrequency

ACTIVE COMPARATOR

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.

Procedure: Group S : Stellate Ganglion supervoltage pulsed radiofrequency

Group T: T2-T3 chains supervoltage pulsed radiofrequency

ACTIVE COMPARATOR

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.

Procedure: Group T : T2-T3 chains supervoltage pulsed radiofrequency.

Group C: Control group on tramadol 150 mg / day and gabapentin 600 mg / day

NO INTERVENTION

Control group on tramadol 150 mg / day and gabapentin 600 mg / day

Interventions

Group S : Stellate Ganglion supervoltage pulsed radiofrequency PROCEDURE

· 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

Group S: Stellate Ganglion super-voltage pulsed radiofrequency

Group T : T2-T3 chains supervoltage pulsed radiofrequency. PROCEDURE

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

Group T: T2-T3 chains supervoltage pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: * Female patients aged 18-60 years. * Patient of class II according to the American society of Anesthesiologists (ASA) physical status classification system . * History of unilateral mastectomy for breast cancer. * Persistent pain \>3 months postoperatively. * VAS score ≥4 despite pharmacological management. * Patients with neuropathic pain who has a score ≥4 by Douleur Neuropathic 4 question (DN4) questionnaire
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18-60 years.
• Patient of class II according to the American society of Anesthesiologists (ASA) physical status classification system.
• History of unilateral mastectomy for breast cancer.
• Persistent pain \>3 months postoperatively.
• VAS score ≥4 despite pharmacological management.
• Patients with neuropathic pain who has a score ≥4 by (DN4) questionnaire.
• Patients on more than 1 antineuropathic drug.

You may not qualify if:

• Coagulopathy or anticoagulant therapy.
• Local infection at injection site.
• History of psychiatric illness or cognitive dysfunction.
• Previous intervention in the same region (e.g., prior stellate ganglion block or thoracic radiofrequency ablation).
• Allergy to local anesthetics or contrast agents.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Soliman

CONTACT

00201286979695; ams21787arif@hotmail.com

Salah Ismail

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia and pain management

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

EG (1)