Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain

Cairo University (CU)

Status: Enrolling

Conditions: Shoulder Pain; Chronic; Pulsed Radiofrequency; Post Mastectomy; Shoulder Individual Nerves Brachial Plexus

Treatments: Other: Brachial plexus pulsed radiofrequency; Other: Control; Other: Sholder individual nerves pulsed radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT07002944

AP2412-201-087-194

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Brachial plexus pulsed radiofrequency group

Other group

Description:

Patients will receive pulsed radiofrequency of brachial plexus with steroids injection.

Treatment:

Other: Brachial plexus pulsed radiofrequency

Sholder individual nerves pulsed radiofrequency group

Other group

Description:

Patients will receive shoulder individual nerves pulsed radiofrequency with steroids injection.

Treatment:

Other: Sholder individual nerves pulsed radiofrequency

Control group

Active Comparator group

Description:

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 .

Treatment:

Other: Control