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Nerveblocks for Persistent Pain After Breast Cancer Surgery

Primary Purpose

Pain, Neuropathic Pain, Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bupivacaine
NaCl
Sponsored by
Kenneth Geving Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain focused on measuring postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    ICBN, active

    ICBN, placebo

    Tenderpoint, active

    Tenderpoint, placebo

    Arm Description

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

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

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

    Ultrasound guided injection of NaCl, 20mL in the tenderpoint

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Pain at rest, pain during movement and pressure pain
    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
    Reduction of physical function

    Full Information

    First Posted
    January 8, 2015
    Last Updated
    October 26, 2015
    Sponsor
    Kenneth Geving Andersen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02336529
    Brief Title
    Nerveblocks for Persistent Pain After Breast Cancer Surgery
    Official Title
    Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kenneth Geving Andersen

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Neuropathic Pain, Breast Cancer
    Keywords
    postoperative

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ICBN, active
    Arm Type
    Experimental
    Arm Description
    Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN
    Arm Title
    ICBN, placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN
    Arm Title
    Tenderpoint, active
    Arm Type
    Experimental
    Arm Description
    Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint
    Arm Title
    Tenderpoint, placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Ultrasound guided injection of NaCl, 20mL in the tenderpoint
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    NaCl
    Primary Outcome Measure Information:
    Title
    Summed pain intensity
    Description
    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
    Time Frame
    At least 1 year after surgery
    Secondary Outcome Measure Information:
    Title
    Pain at rest, pain during movement and pressure pain
    Description
    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)
    Time Frame
    At least 1 year after surgery
    Title
    Pain related reduction of physical function
    Description
    Reduction of physical function
    Time Frame
    At least 1 year after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nelun Wijayasinghe, MD
    Phone
    +4535454496
    Email
    nelun.wijayasinghe@regionh.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nelun Wijayasinghe, MD
    Organizational Affiliation
    Rigshospitalet, University of Copenhagen
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kenneth G Andersen, MD, PhD
    Organizational Affiliation
    Rigshospitalet, University of Copenhagen
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24918332
    Citation
    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.
    Results Reference
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    Nerveblocks for Persistent Pain After Breast Cancer Surgery

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