Breast Cancer
Conditions
Brief summary
Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post mastectomy pain syndrome . After breast cancer surgery, between 6% and 86% of people may develop tight bands of fibrous tissue under their skin, known as axillary web syndrome. These bands can cause pain in the shoulder area by trying to raise or extend the arm. Shoulder pain is a common side effect of breast cancer surgery and treatment. Various medical and interventional procedures have been tried for treating postmastectomy shoulder pain, with varying efficacy . Among the interventional procedures that may have a role for treatment. Innervation of the glenohumeral joint (GHJ) can be divided into anterior and posterior innervation from articular branches of the suprascapular nerve (SN):C5 &6 (posterior-lateral), axillary nerve (AN):C5 &6 (anterior-lateral, inferior, and posteriorlateral), and lateral pectoral nerve (LPN): C5 &6 (anterior superior)
Detailed description
The investigators hypothesize that thermal RF (radiofrequency) of shoulder individual nerves is efficacious for the management of post-mastectomy shoulder pain.
Interventions
DEVICE(Shoulder individual nerves TRF (thermal radio frequency): Patients will receive shoulder individual nerves Thermal RF.
Shoulder individual nerves thermal RF technique: The patient will be put in the sitting position, monitored with electrocardiography, pulse oximetry, and non-invasive blood pressure. after disinfection A high-frequency linear transducer (10-15 Hz) will be placed parallel and cephalad to the spine of the scapula. The probe will be moved from cephalad to caudad until the trapezius and supraspinatus muscles were identified. The suprascapular nerve will be identified as a hyperechogenic structure in the suprascapular fossa deep to the superior transverse scapular ligament. A 10 cm radiofrequency needle, with a 10 mm active tip, will be inserted in plane with the ultrasound beam and advanced to reach the proximity to the nerve. A nerve stimulator was used as an additional nerve-finding modality.
DRUGconservative treatment
Patients will receive conservative treatment Acetaminophen (paracetamol 1000 mg tid and pregabalin (lyrica) 75 mg bid; can be increased to 150 mg bid, oxycodone (oxynorm) 10mg IR PRN.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age (18-65) Years. 2. ASA physical status (II- III). 3. Patients with post mastectomy irradiation shoulder pain. 4. Body mass index (BMI): (20-40) kg/m2.
Exclusion criteria
1. Patient refusal. 2. Known sensitivity or contraindication to drugs used in the study. 3. Pregnancy. 4. Recent myocardial infarction. 5. Hemodynamically unstable. 6. Local and systemic sepsis. 7. Psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the changes in NPRS (numerical pain rating scale) for assessment of pain relief which will be recorded before treatment and at 1 month, 2 months and 3-month intervals following treatment. | 1 month, 2 months and 3-month intervals following treatment. | numerical pain rating scale is a measurement tool that uses numbers to represent the intensity of a characteristic or quality, where 0 might represent "no pain" and 100 the highest number represents "the worst pain imaginable". |
Secondary
| Measure | Time frame |
|---|---|
| Measure oxycodone IR (immediate release) consumption | 1 month, 2 months and 3-month intervals following treatment. |
Countries
Egypt
Contacts
CONTACTsuzan Adlan
Outcome results
None listed