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

Persistent Pain After Breast Cancer Surgery Clinical Trial

— PPBCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349581
• Other study ID #: H-6-2014-036
• Status: Recruiting
• Phase: Phase 2
• First received: January 13, 2015
• Last updated: January 23, 2015
• Start date: November 2014

Study information

• Verified date: January 2015
• Source: Rigshospitalet, Denmark
• Contact: Nelun Wijayasinghe, MBBS, BSc
• Phone: +45 35456643
• Email: nelun.wijayasinghe[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Persistent Pain After Breast Cancer Surgery

Intervention

Procedure:
• PECS block
Ultrasound guided delivery of local anesthetic between the pectoral muscles

Drug:
• Bupivacaine

Locations

Country	Name	City	State
Denmark	Section for surgical pathophysiology 7621 Rigshospitalet	Copenhagen	Sjaelland

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Henrik Kehlet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Longer term effects (Daily pain scores and functional questionnaire)	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	No
Primary	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	No
Secondary	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	30 minutes after blockade	No