Combining two types of radiofrequency ablation for post-mastectomy pain relief
Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
This study is testing if combining two types of pain relief injections can help women with severe pain after breast surgery feel better than using just one type of injection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | National Cancer Institute, Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06033456 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining ultrasound-guided radiofrequency stellate ganglion block (SGB) and thoracic paravertebral block (TPVB) in treating post-mastectomy pain syndrome (PMPS). It aims to compare this combined approach to using either SGB or TPVB alone. The study focuses on female patients who have undergone modified radical mastectomy and are experiencing moderate to severe pain that has not responded to strong opioids and adjuvant therapies. The goal is to provide a more effective pain management strategy for those suffering from complex regional pain syndrome following breast cancer surgery.
Who should consider this trial
Good fit: Ideal candidates are female patients who have undergone modified radical mastectomy and are experiencing moderate to severe refractory pain for more than six months.
Not a fit: Patients with severe respiratory or cardiac disorders, advanced liver or kidney disease, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for women suffering from post-mastectomy pain syndrome.
How similar studies have performed: While the combination of these specific interventions is novel, similar approaches in pain management have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- National Cancer Institute — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mary S Gerges
- Email: Marysabry136@gmail.com
- Phone: 00201222610774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.