NCT02349581

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

January 13, 2015

Last Update Submit

January 23, 2015

Conditions

Persistent Pain After Breast Cancer Surgery

Keywords

Anesthetics, LocalMastectomyNeuralgiaNerve block

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes after blockade

Secondary Outcomes (1)

  • Differences in quantitative sensory testing (QST) values

    30 minutes after blockade

Other Outcomes (1)

  • Longer term effects (Daily pain scores and functional questionnaire)

    1 week after blockade

Study Arms (2)

Block

EXPERIMENTAL

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

Procedure: PECS blockDrug: Bupivacaine

Sonoanatomy

NO INTERVENTION

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

Interventions

PECS blockPROCEDURE

Ultrasound guided delivery of local anesthetic between the pectoral muscles

Block
BupivacaineDRUG
Block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section for surgical pathophysiology 7621 Rigshospitalet

Copenhagen, Region Sjælland, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Henrik Kehlet, MD, PhD, DMsc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Central Study Contacts

Nelun Wijayasinghe, MBBS, BSc

CONTACT

+45 35456643nelun.wijayasinghe@regionh.dk

Kenneth G Andersen, MD, PhD

CONTACT

+45 35 45 66 43kenneth.geving.andersen@rh.regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, clinical researcher

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 29, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

DK(1)