Comparing alcohol and thermal methods for treating chronic pain after breast surgery
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
This study is testing whether an alcohol injection or a heat treatment can help women with chronic pain after breast surgery feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | Female |
| Sponsor | National Cancer Institute, Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05771103 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different techniques for stellate ganglion destruction in women suffering from chronic post-mastectomy pain syndrome. Participants will be randomly assigned to receive either an alcohol injection or thermal radiofrequency neurolysis, both guided by ultrasound and fluoroscopy. The study focuses on patients who have experienced moderate to severe neuropathic pain for more than six months following breast cancer surgery. The goal is to determine which method provides better pain relief and improves quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-65 who have undergone surgery for breast cancer and have experienced moderate to severe neuropathic pain for over six months.
Not a fit: Patients with recent myocardial infarction, severe emphysema, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from chronic pain after breast cancer surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing chronic pain, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patient 20-65yrs underwent surgery for breast cancer * Pain duration of more than 6 months * Pain is moderate to severe pain (visual analog scale \[VAS\] ≥ 4 cm), * Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective * Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4 Exclusion Criteria: * Refusal of the patient * Recent myocardial infarction * Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio) * Glaucoma * Pre-existing counter lateral nerve palsy * Severe emphysema * Cardiac conduction block * Local and systemic sepsis * Local anatomical distortion (which may render the block technically difficult or hazardous. * Psychiatric illness.
Where this trial is running
Cairo
- NCIEgypt IRB office — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: suzan adlan, lecturer — National Cancer Institute, Egypt
- Study coordinator: suzan adlan, lecturer
- Email: dr_s.adlan@hotmail.com
- Phone: 01111068300
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.