NCT02336529

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

January 8, 2015

Last Update Submit

October 26, 2015

Conditions

PainNeuropathic PainBreast Cancer

Keywords

postoperative

Outcome Measures

Primary Outcomes (1)

  • Summed pain intensity

    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 Outcomes (2)

  • Pain at rest, pain during movement and pressure pain

    At least 1 year after surgery

  • Pain related reduction of physical function

    At least 1 year after surgery

Study Arms (4)

ICBN, active

EXPERIMENTAL

Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN

Drug: Bupivacaine

ICBN, placebo

PLACEBO COMPARATOR

Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN

Drug: NaCl

Tenderpoint, active

EXPERIMENTAL

Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint

Drug: Bupivacaine

Tenderpoint, placebo

PLACEBO COMPARATOR

Ultrasound guided injection of NaCl, 20mL in the tenderpoint

Drug: NaCl

Interventions

BupivacaineDRUG
ICBN, activeTenderpoint, active
NaClDRUG
ICBN, placeboTenderpoint, placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.

    PMID: 24918332BACKGROUND

MeSH Terms

Conditions

PainNeuralgiaBreast Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nelun Wijayasinghe, MD

    Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Kenneth G Andersen, MD, PhD

    Rigshospitalet, University of Copenhagen

    STUDY CHAIR

Central Study Contacts

Nelun Wijayasinghe, MD

CONTACT

+4535454496nelun.wijayasinghe@regionh.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 27, 2015

Record last verified: 2015-10