Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome

Launched by NATIONAL CANCER INSTITUTE, EGYPT · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help women who have persistent pain after a mastectomy, which is the surgical removal of breast tissue. The researchers want to see if combining two treatments—one that targets a group of nerves in the neck (called stellate ganglion block) and another that focuses on the area around the spine (thoracic paravertebral block)—can provide better pain relief than using either treatment alone. The goal is to help women who have been suffering from this pain for more than six months and who find it difficult to manage even with strong pain medications.

To participate in this trial, women must have had a modified radical mastectomy and be experiencing moderate to severe pain that hasn't improved with other treatments. They should also be in fair to good health. Unfortunately, not everyone will be eligible; for example, those with certain medical conditions, severe heart or lung diseases, or who are pregnant cannot join. If eligible, participants can expect to receive either the combined treatment or the individual treatments, and all care will be guided by medical professionals. This trial is currently recruiting participants, aiming to provide hope for better pain management in the future.

Gender

FEMALE

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.