A Phase 2 interventional study of PECS block and Bupivacaine in Persistent Pain After Breast Cancer Surgery, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-29.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 6 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine
Procedure: PECS block · Drug: Bupivacaine
16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block
Ultrasound guided delivery of local anesthetic between the pectoral muscles
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
Time frame: 30 minutes after blockade
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
Time frame: 30 minutes after blockade
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.
Time frame: 1 week after blockade
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark