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

January 23, 2015 updated by: Nelun Wijayasinghe, Rigshospitalet, Denmark

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes after blockade

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in quantitative sensory testing (QST) values
Time Frame: 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
30 minutes after blockade

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longer term effects (Daily pain scores and functional questionnaire)
Time Frame: 1 week after blockade
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.
1 week after blockade

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Kehlet, Henrik, M.D., Ph.D.

Investigators

  • Study Director: Henrik Kehlet, MD, PhD, DMsc, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-6-2014-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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