Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
Overview
- Phase
- Phase 3
- Intervention
- Bupivacaine
- Conditions
- Pain
- Sponsor
- Kenneth Geving Andersen
- Enrollment
- 48
- Primary Endpoint
- Summed pain intensity
- Last Updated
- 10 years ago
Overview
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.
Investigators
Kenneth Geving Andersen
Research fellow
Rigshospitalet, Denmark
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
Arms & Interventions
ICBN, active
Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN
Intervention: Bupivacaine
ICBN, placebo
Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN
Intervention: NaCl
Tenderpoint, active
Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint
Intervention: Bupivacaine
Tenderpoint, placebo
Ultrasound guided injection of NaCl, 20mL in the tenderpoint
Intervention: NaCl
Outcomes
Primary Outcomes
Summed pain intensity
Time Frame: 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 Outcomes
- Pain at rest, pain during movement and pressure pain(At least 1 year after surgery)
- Pain related reduction of physical function(At least 1 year after surgery)