Nerveblocks for Persistent Pain After Breast Cancer Surgery

Kenneth Geving Andersen

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer; Neuropathic Pain; Pain

Treatments: Drug: Bupivacaine; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT02336529

H-3-2013-172

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

ICBN, active

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

ICBN, placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl

Tenderpoint, active

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Tenderpoint, placebo

Placebo Comparator group

Description:

Ultrasound guided injection of NaCl, 20mL in the tenderpoint

Treatment:

Drug: NaCl