Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome
- Conditions
- Complex Regional Pain SyndromesStellate GanglionRadiofrequency AblationMastectomy
- Registration Number
- NCT06033456
- Lead Sponsor
- National Cancer Institute, Egypt
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The degree of pain relief 3 months after intervention Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention.
Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.
- Secondary Outcome Measures
Name Time Method Patient satisfaction 3 months after intervention Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
Patient's Quality of life 3 months Patient's Quality of life according to WHOQOL(who measure quality of life)
Oxycodone consumption 3 months after intervention The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Pregabalin consumption 3 months after intervention The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.
neuropathic pain 3 months Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP).
Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) .
The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)
Trial Locations
- Locations (1)
National Cancer Institute
🇪🇬Cairo, Egypt
National Cancer Institute🇪🇬Cairo, EgyptMary S Gerges, MDContact00201222610774Marysabry136@gmail.comMahmoud A Kamel, MDSub InvestigatorTaher S Thabet, MDSub InvestigatorSuzan A Abdel rahman, MDSub InvestigatorHossam Z Ghobrial, MDSub Investigator