Nerveblocks for Persistent Pain After Breast Cancer Surgery

October 26, 2015 updated by: Kenneth Geving Andersen

Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery

Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • At least 1 year after surgery for breast cancer
  • Women aged 18 or over
  • Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)

Exclusion Criteria:

  • Previous cosmetic surgery
  • bilateral cancer
  • pregnant or lactating
  • other disease in the nervous system
  • in treatment for psychiatric disease
  • unable to understand Danish
  • unable to give informed concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICBN, active
Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN
Drug: Bupivacaine
Placebo Comparator: ICBN, placebo
Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN
Drug: NaCl
Experimental: Tenderpoint, active
Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint
Drug: Bupivacaine
Placebo Comparator: Tenderpoint, placebo
Ultrasound guided injection of NaCl, 20mL in the tenderpoint
Drug: NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summed pain intensity
Time Frame: At least 1 year after surgery
The summed pain intensity (of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)) 0-30
At least 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at rest, pain during movement and pressure pain
Time Frame: At least 1 year after surgery
Pain intensity of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)
At least 1 year after surgery
Pain related reduction of physical function
Time Frame: At least 1 year after surgery
Reduction of physical function
At least 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Geving Andersen

Investigators

  • Principal Investigator: Nelun Wijayasinghe, MD, Rigshospitalet, University of Copenhagen
  • Study Chair: Kenneth G Andersen, MD, PhD, Rigshospitalet, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-172

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe