Nerveblocks for Persistent Pain After Breast Cancer Surgery

Phase 3

• Conditions: Neuropathic Pain; Pain; Breast Cancer
• Interventions: Drug: NaCl; Drug: Bupivacaine

• Registration Number: NCT02336529
• Lead Sponsor: Kenneth Geving Andersen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-27
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ICBN, placebo	NaCl	Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN
Tenderpoint, placebo	NaCl	Ultrasound guided injection of NaCl, 20mL in the tenderpoint
ICBN, active	Bupivacaine	Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN
Tenderpoint, active	Bupivacaine	Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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