Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery

Study Overview
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Brief Summary
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This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.

Detailed Description
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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.

Official Title
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Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery

Conditions
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Persistent Pain After Breast Cancer Surgery

Intervention / Treatment
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* Procedure: PECS block
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Block<br>Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine | Procedure: PECS block<br>* Ultrasound guided delivery of local anesthetic between the pectoral muscles<br>Drug: Bupivacaine<br> <br> |
| No Intervention: Sonoanatomy<br>16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Local, Mastectomy, Neuralgia, Nerve block