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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorNational Cancer Institute, Egypt

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group S : Stellate Ganglion supervoltage pulsed radiofrequency

    Procedure/Surgery

    · 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 T : T2-T3 chains supervoltage pulsed radiofrequency.

    Procedure/Surgery

    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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group S: Stellate Ganglion super-voltage pulsed radiofrequencyActive comparator 1 intervention
Group B: Group T: T2-T3 chains supervoltage pulsed radiofrequencyActive comparator 1 intervention
Group C: Group C: Control group on tramadol 150 mg / day and gabapentin 600 mg / dayNo intervention 0 interventions

Trial outcomes

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)

Time frame
6 months

Secondary outcomes

1

Change in Brief Pain Inventory in groups.

Change in Brief Pain Inventory (BPI) score reflecting functional improvement.

Time frame
6 months
2

Patient satisfaction

Patient satisfaction using patient global impression of change (PGIC)scale

Time frame
6 months
3

dose reduction in antineuropathic drugs

dose reduction in antineuropathic drugs

Time frame
6 months
4

procedural complications.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: