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Clinical Trials/NCT02349581
NCT02349581
Unknown
Phase 2

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

Rigshospitalet, Denmark1 site in 1 country6 target enrollmentNovember 2014

Overview

Phase
Phase 2
Intervention
PECS block
Conditions
Persistent Pain After Breast Cancer Surgery
Sponsor
Rigshospitalet, Denmark
Enrollment
6
Locations
1
Primary Endpoint
Differences in summed pain intensity score (SPI)
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
May 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nelun Wijayasinghe

Anesthesiologist, clinical researcher

Rigshospitalet, Denmark

Eligibility Criteria

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

Arms & Interventions

Block

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

Intervention: PECS block

Block

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

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Differences in summed pain intensity score (SPI)

Time Frame: 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 Outcomes

  • Differences in quantitative sensory testing (QST) values(30 minutes after blockade)

Study Sites (1)

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