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

NCT ID: NCT02349581

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Persistent Pain After Breast Cancer Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Block

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

Group Type EXPERIMENTAL

PECS block

Intervention Type PROCEDURE

Ultrasound guided delivery of local anesthetic between the pectoral muscles

Bupivacaine

Intervention Type DRUG

Sonoanatomy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PECS block

Ultrasound guided delivery of local anesthetic between the pectoral muscles

Intervention Type PROCEDURE

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

INDIV

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Nelun Wijayasinghe

Anesthesiologist, clinical researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henrik Kehlet, MD, PhD, DMsc

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Section for surgical pathophysiology 7621 Rigshospitalet

Copenhagen, Region Sjælland, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Nelun Wijayasinghe, MBBS, BSc

Role: CONTACT

+45 35456643

Kenneth G Andersen, MD, PhD

Role: CONTACT

+45 35 45 66 43

Facility Contacts

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Nelun Wijayasinghe, MBBS, BSc

Role: primary

+45 35456643

Kenneth G Andersen, MD, PhD

Role: backup

+45 35456643

Other Identifiers

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H-6-2014-036

Identifier Type: -

Identifier Source: org_study_id

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