Nerveblocks for Persistent Pain After Breast Cancer Surgery

Study Overview
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Brief Summary
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Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.

Official Title
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Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery

Conditions
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Pain, Neuropathic Pain, Breast Cancer

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1 year after surgery for breast cancer Women aged 18 or over Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over) Exclusion Criteria: Previous cosmetic surgery bilateral cancer pregnant or lactating other disease in the nervous system in treatment for psychiatric disease unable to understand Danish unable to give informed concent

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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICBN, active<br>Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN | Drug: Bupivacaine<br> <br> |
| Placebo Comparator: ICBN, placebo<br>Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN | Drug: NaCl<br> <br> |
| Experimental: Tenderpoint, active<br>Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint | Drug: Bupivacaine<br> <br> |
| Placebo Comparator: Tenderpoint, placebo<br>Ultrasound guided injection of NaCl, 20mL in the tenderpoint | Drug: NaCl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed pain intensity | The summed pain intensity (of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)) 0-30 | At least 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest, pain during movement and pressure pain | Pain intensity of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10) | At least 1 year after surgery | 
| Pain related reduction of physical function | Reduction of physical function | At least 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative