Persistent Pain After Breast Cancer Surgery
Conditions
Keywords
Anesthetics, Local, Mastectomy, Neuralgia, Nerve block
Brief summary
This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.
Detailed description
This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.
Interventions
PROCEDUREPECS block
Ultrasound guided delivery of local anesthetic between the pectoral muscles
DRUGBupivacaine
Sponsors
Kehlet, Henrik, M.D., Ph.D.
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients, aged 18 years or over, treated for breast cancer * Patients with persistent pain in the breast after surgical treatment for breast cancer. Their pain score must be 4 or more on the numerical rating scale (NRS).
Exclusion criteria
* breast surgery within the last 12 months * previous cosmetic surgery * bilateral breast cancer (receiving bilateral intervention) * pregnant or breast feeding * neurological disease * on-going treatment for severe mental illness or who abuse alcohol or drugs * are unable to understand written or spoken Danish or English * lack mental capacity to give informed consent or cooperate with the neurophysiological testing * an allergy to amide local anaesthetics * pacemaker in situ * received treatment outside guidelines and recommendations from the Danish Breast Cancer Co-operative Group (DBCG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in summed pain intensity score (SPI) | 30 minutes after blockade | SPI is a combination of pain at rest + pain on arm abduction + pain with 100kPa pressure. SPI will be taken before and 30 minutes after the PECS block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in quantitative sensory testing (QST) values | 30 minutes after blockade | QST consists of sensory mapping (delineating areas of hypo/hyperesthesia and/or allodynia), warm detection thresholds, cool detection thresholds, heat pain thresholds, suprathermal heat pain response and pressure pain thresholds. These will be measured before and 30 minutes after the PECS block |
Other
| Measure | Time frame | Description |
|---|---|---|
| Longer term effects (Daily pain scores and functional questionnaire) | 1 week after blockade | Patients will complete a pain diary for 5 consecutive days before administration of the PECS block and 7 consecutive days after the block. The patients also complete a functional questionnaire the day before the block and again exactly one week after the block. |
Countries
Denmark
Contacts
Primary ContactNelun Wijayasinghe, MBBS, BSc
Backup ContactKenneth G Andersen, MD, PhD
Outcome results
None listed