Status:
UNKNOWN
Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Post-surgical Pain
Pain, Chronic
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Sacrifice of the intercostobrachial nerve (ICBN) during surgery is associated with development of persistent post-surgical pain (PPSP), which affects up to 60% of breast cancer surgery patients. A lar...
Detailed Description
A 2016 systematic review that included 30 observational studies (n= 19,813 patients) found high quality evidence that axillary lymph node dissection (ALND) is associated with a 21% absolute risk incre...
Eligibility Criteria
Inclusion
- Pilot Study
- Females aged 18 years and older.
- Known or suspected invasive breast cancer.
- Planned ALND (not sentinel lymph node biopsy) either alone or with planned mastectomy or breast conserving surgery.
- The ICBN is preservable (as confirmed in the OR)
- Cognitive ability and language skills required to complete the outcome measures.
- Provision of informed consent.
Exclusion
- The patient has chronic pain or a chronic pain syndrome for which they have received daily medication (i.e. opioid, anti-convulsant, anti-spasmodic, anti-depressant, anti-inflammatory) or routine pain intervention (i.e. nerve blocks) during the past 3 months.
- Note: Chronic pain refers to known chronic pain disorder (i.e. post-herpetic neuralgia, complex regional pain syndrome, fibromyalgia, diabetic neuropathy, post-stroke pain, etc.). The diagnosis for a 'chronic pain syndrome' is outlined by the use of pain medications and interventions. The pain medication must be used by the patient to treat pain. For a pain intervention to be considered routine, it must be given in its prescribed frequency during the past three months (e.g. a patient that has been prescribed to receive a nerve block once a month, received three nerve blocks in the past three months).
- The patient has a prior history of completing ALND on the ipsilateral side.
- Detectable metastatic disease at the time of initial diagnosis.
- Planned bilateral ALND.
- History of shoulder trauma or pathology on the same side as their breast cancer.
- Preservation of the ICBN is not possible, in the judgement of the attending surgeon (as confirmed in the OR).
- Anticipated problems with the patient being available for follow-up.
- Incarceration.
- The patient is or may be enrolled in a competing trial.
- Other reason to exclude the patient, as specified.
- Biomarker Sub-Study Eligibility:
- All eligible patients who consent to participate in the INSPIRE trial will be asked to participate in the biomarker sub-study. Participants who decline to participate in the biomarker sub-study will still be enrolled into the INSPIRE trial. During the pilot phase of the INSPIRE trial, we will confirm our ability to obtain and analyze blood samples from ≥ 90% of INSPIRE participants.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03421522
Start Date
October 15 2019
End Date
December 1 2020
Last Update
June 26 2020
Active Locations (1)
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1
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3