Nerveblocks for Persistent Pain After Breast Cancer Surgery

Sponsor

Kenneth Geving Andersen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02336529

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Neuropathic Pain Breast Cancer	Drug: Bupivacaine Drug: NaCl	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Summed pain intensity [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

Secondary Outcome Measures

Pain at rest, pain during movement and pressure pain [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)
Pain related reduction of physical function [At least 1 year after surgery]
Reduction of physical function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kenneth Geving Andersen

Investigators

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