Nerveblocks for Persistent Pain After Breast Cancer Surgery

NCT ID: NCT02336529

Last Updated: 2015-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Neuropathic Pain Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICBN, active

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

ICBN, placebo

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

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

Tenderpoint, active

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Tenderpoint, placebo

Ultrasound guided injection of NaCl, 20mL in the tenderpoint

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

Intervention Type DRUG

NaCl

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kenneth Geving Andersen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kenneth Geving Andersen

Research fellow

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nelun Wijayasinghe, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, University of Copenhagen

Kenneth G Andersen, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nelun Wijayasinghe, MD

Role: CONTACT

+4535454496

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24918332 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-3-2013-172

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Post Breast Surgery Pain
NCT00847067 TERMINATED NA
Pectoral Nerve Blockade in Mastectomy
NCT01943240 WITHDRAWN PHASE4
Pectoral Nerves Blocks for Chronic Pain
NCT02719795 UNKNOWN EARLY_PHASE1