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

Phase 2

• Conditions: Persistent Pain After Breast Cancer Surgery
• Interventions: Procedure: PECS block; Drug: Bupivacaine

• Registration Number: NCT02349581
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-01
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-23
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Block	PECS block	Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine
Block	Bupivacaine	Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Section for surgical pathophysiology 7621 Rigshospitalet; 🇩🇰 Copenhagen, Sjaelland, Denmark