Nerveblocks for Persistent Pain After Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02336529
• Other study ID #: H-3-2013-172
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 8, 2015
• Last updated: October 26, 2015
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: Nelun Wijayasinghe, MD
• Phone: +4535454496
• Email: nelun.wijayasinghe[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuralgia
• Neuropathic Pain
• Pain

Intervention

Drug:
• Bupivacaine

• NaCl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Geving Andersen

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	At least 1 year after surgery	No
Secondary	Pain related reduction of physical function	Reduction of physical function	At least 1 year after surgery	No