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

Primary Purpose

Persistent Pain After Breast Cancer Surgery

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
PECS block
Bupivacaine
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Pain After Breast Cancer Surgery focused on measuring Anesthetics, Local, Mastectomy, Neuralgia, Nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Section for surgical pathophysiology 7621 RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Block

Sonoanatomy

Arm Description

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

16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2015
Last Updated
January 23, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Kehlet, Henrik, M.D., Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02349581
Brief Title
Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery
Acronym
PPBCS
Official Title
Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Kehlet, Henrik, M.D., Ph.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pain After Breast Cancer Surgery
Keywords
Anesthetics, Local, Mastectomy, Neuralgia, Nerve block

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Block
Arm Type
Experimental
Arm Description
Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine
Arm Title
Sonoanatomy
Arm Type
No Intervention
Arm Description
16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block
Intervention Type
Procedure
Intervention Name(s)
PECS block
Intervention Description
Ultrasound guided delivery of local anesthetic between the pectoral muscles
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Primary Outcome Measure Information:
Title
Differences in summed pain intensity score (SPI)
Description
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
Time Frame
30 minutes after blockade
Secondary Outcome Measure Information:
Title
Differences in quantitative sensory testing (QST) values
Description
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
Time Frame
30 minutes after blockade
Other Pre-specified Outcome Measures:
Title
Longer term effects (Daily pain scores and functional questionnaire)
Description
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.
Time Frame
1 week after blockade

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 received treatment outside guidelines and recommendations from the Danish Breast Cancer Co-operative Group (DBCG)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelun Wijayasinghe, MBBS, BSc
Phone
+45 35456643
Email
nelun.wijayasinghe@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth G Andersen, MD, PhD
Phone
+45 35 45 66 43
Email
kenneth.geving.andersen@rh.regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Kehlet, MD, PhD, DMsc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Section for surgical pathophysiology 7621 Rigshospitalet
City
Copenhagen
State/Province
Sjaelland
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelun Wijayasinghe, MBBS, BSc
Phone
+45 35456643
Email
nelun.wijayasinghe@regionh.dk
First Name & Middle Initial & Last Name & Degree
Kenneth G Andersen, MD, PhD
Phone
+45 35456643
Email
kenneth.geving.andersen@rh.regionh.dk

12. IPD Sharing Statement

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

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