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| Name | Class |
|---|---|
| Kehlet, Henrik, M.D., Ph.D. | INDIV |
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This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Block | Experimental | Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine |
|
| Sonoanatomy | No Intervention | 16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECS block | Procedure | Ultrasound guided delivery of local anesthetic between the pectoral muscles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in summed pain intensity score (SPI) | 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 | 30 minutes after blockade |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in quantitative sensory testing (QST) values | 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 | 30 minutes after blockade |
| Measure | Description | Time Frame |
|---|---|---|
| Longer term effects (Daily pain scores and functional questionnaire) | 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. | 1 week after blockade |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nelun Wijayasinghe, MBBS, BSc | Contact | +45 35456643 | nelun.wijayasinghe@regionh.dk | |
| Kenneth G Andersen, MD, PhD | Contact | +45 35 45 66 43 | kenneth.geving.andersen@rh.regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Kehlet, MD, PhD, DMsc | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Section for surgical pathophysiology 7621 Rigshospitalet | Recruiting | Copenhagen | Region Sjælland | 2100 | Denmark |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine |
| Drug |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |