Clinical trial NCT06033456: Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome
Official title: Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stellate Ganglion
Radiofrequency Ablation
Complex Regional Pain Syndromes
Mastectomy
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.

Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.

Eligibility criteria: Inclusion Criteria:

* Female patients.
* Type of surgery: Modified Radical Mastectomy MRM.
* Physical status ASA II, III.
* Duration of more than 6 months and less than 2 years.
* Moderate and severe pain (visual analog scale \[VAS\] ≥ 40 mm).
* Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.

Exclusion Criteria:

* Patient refusal.
* Patient with local and systemic sepsis.
* Local anatomical distortion.
* History of contralateral chest disease or pneumonectomy.
* Known sensitivity or contraindication to the drug used in the study.
* History of psychological disorders.
* Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.
* Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
* Pregnancy.
* Physical status ASA IV and Male patients.

Primary outcomes:
measure: The degree of pain relief
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 months after intervention
measure: Oxycodone consumption
timeFrame: 3 months after intervention
measure: Pregabalin consumption
timeFrame: 3 months after intervention
measure: neuropathic pain
timeFrame: 3 months
measure: Patient's Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
References: