Chronic, Post Mastectomy, Pulsed Radiofrequency, Shoulder Individual Nerves Brachial Plexus, Shoulder Pain
Conditions
Brief summary
this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.
Detailed description
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. Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .
Interventions
OTHERBrachial plexus pulsed radiofrequency
Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.
OTHERSholder individual nerves pulsed radiofrequency
Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.
OTHERControl
Patients will receive conservative treatment (paracetamol 1000 tid and pregabalin 75 mg bid; can be increased to 150 mg bid , oxycodone 10 mg oral every 12 hrs .
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age (18-65) Years. * American Society of Anesthesiologists (ASA) physical status (II- III). * Patients with post mastectomy shoulder pain. * Body mass index (BMI): (20-40) kg/m2. * Patients on maximum daily dose tramadol ( 450mg ) and still in pain
Exclusion criteria
* Patient refusal. * Known sensitivity or contraindication to drugs used in the study. * Pregnancy. * Recent myocardial infarction. * Hemodynamically unstable. * Local and systemic sepsis. * Psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in visual Analogue Scale (VAS ) | 24 weeks post postoperatively | Changes in visual Analogue Scale (VAS )for assessment of pain relief. A 100 mm horizontal line version will be used with 2 ends (left-end means no pain and right-end means the worst pain). This version is preferred in research studies for chronic pain status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement | 24 weeks post postoperatively | This is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into 4 categories (0-25%) ≈ no or minimal functional improvement, (\> 25- 50%) ≈ mild improvement, (\> 50-75%) ≈ moderate improvement, and (\>75-100%) ≈ marked improvement. |
| Analgesic consumption | 24 weeks post postoperatively | Analgesic consumption will be recorded |
| Patient satisfaction | 24 weeks post postoperatively | Satisfaction scores of 0 dissatisfied and 10 very satisfied will be assessed |
| The impact of treatment on the quality of life of the patient | 24 weeks post postoperatively | The impact of treatment on the quality of life of the patient, which will be assessed by the SF-36 questionnaire. |
| Incidence of complications | 24 weeks post postoperatively | Incidence of complications will be recorded |
Countries
Egypt
Contacts
Primary ContactYasmina S Ismail, Master
Outcome results
None listed