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

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: Persistent Pain After Breast Cancer Surgery
• Intervention / Treatment: Drug: Bupivacaine; Procedure: PECS block

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

• Study Contact: Name: Nelun Wijayasinghe, MBBS, BSc; Phone Number: +45 35456643; Email: nelun.wijayasinghe@regionh.dk
• Study Contact Backup: Name: Kenneth G Andersen, MD, PhD; Phone Number: +45 35 45 66 43; Email: kenneth.geving.andersen@rh.regionh.dk

Study Locations

• Denmark
  • Sjaelland
    • Copenhagen, Sjaelland, Denmark, 2100
      • Recruiting
      • Section for surgical pathophysiology 7621 Rigshospitalet
      • Contact: Nelun Wijayasinghe, MBBS, BSc; Phone Number: +45 35456643; Email: nelun.wijayasinghe@regionh.dk
      • Contact: Kenneth G Andersen, MD, PhD; Phone Number: +45 35456643; Email: kenneth.geving.andersen@rh.regionh.dk

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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)	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

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Kehlet, Henrik, M.D., Ph.D.
• Investigators: Study Director: Henrik Kehlet, MD, PhD, DMsc, Rigshospitalet, Denmark

Study record dates

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: Mastectomy; Anesthetics, Local; Nerve block; Neuralgia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: H-6-2014-036