pijn postmastectomy pain syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-65 years Chronic pain (>6 m duration) of the anterior chest wall and / or axilla following breast surgery for cancer Pain intensity > 4 according to NRS At least one other sensory symptom indicating the neuropathic nature of the pain > 50% reduction of pain-intensity following test- block of the ipsilateral spinal nerve TH 1 in subjects with predominant axillary pain or spinal nerve TH 6 with predominant pain of the thoracic wall.
Exclusion criteria
Exclusion criteria: Proven metastases Impaired coagulation Non-surgery related pain of the chest wall Other diseases impairing nerve function Psychiatric disease, dementia Language barriers No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the intensity of pain with 90° abduction of the ipsilateral shoulder 3 weeks following PRF measured by the Numerical Rating Scale [NRS] (0=no pain and 10=worst imaginable pain) and the daily dose of analgesics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are changes in sensory disturbances of the thoracic wall and / or axilla as measured by Quantitative Sensory Testing (QST ) according to the protocol of the German Research Network on Neuropathic pain, the globally perceived effect of the treatment [Likert scale 7 P= 75% improvement - Very good, 6P = 50-74% improvement - Good, 5P = 25-49% improvement - Fairly good, 4P = 0-24% improvement or worse - Same as before, 3P = 25-49 % worse - Fairly bad, 2P = 50-74% worse - Bad, 1 P = 75% worse - Very bad] and the duration of the analgesic effect in weeks. Socioepidemiological data (age, weight, marital state, number of children, employment, highest academic degree) Clinical parameters (type of surgery, anesthesiologic management, postoperative pain, surgical complications postoperative, additional oncological treatments, precise onset en duration of pain, development of PMPS, additional chronic pain localisations) Fear and depression [HADS] [24] Impact of pain on daily activities [VRS 0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=a lot] [8] Quality of life [SF-36] [25] Adverse events and symptoms out [VRS 0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=a lot] | — |
Countries
Netherlands