Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain

Launched by MCMASTER UNIVERSITY · Jan 29, 2018

Keywords

ClinConnect Summary

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 increase of PPSP (95% CI = 13% to 29%). In many cases of breast cancer, surgery involves axillary approaches; however, preliminary evidence suggests that preservation of the intercostobrachial nerves (ICBN) may reduce the incidence of PPSP after axillary clearance. A 2014 systematic review found 3 small, single-center randomized controlled trials (RCTs), that enrolled a total of 309 patients, and ex...

Gender

FEMALE

Eligibility criteria

• • Pilot Study
• Inclusion Criteria:
• • 1. Females aged 18 years and older.
• • 2. Known or suspected invasive breast cancer.
• • 3. Planned ALND (not sentinel lymph node biopsy) either alone or with planned mastectomy or breast conserving surgery.
• • 4. The ICBN is preservable (as confirmed in the OR)
• • 5. Cognitive ability and language skills required to complete the outcome measures.
• • 6. Provision of informed consent.
• Exclusion Criteria:
• • 1. 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).
• • 2. The patient has a prior history of completing ALND on the ipsilateral side.
• • 3. Detectable metastatic disease at the time of initial diagnosis.
• • 4. Planned bilateral ALND.
• • 5. History of shoulder trauma or pathology on the same side as their breast cancer.
• • 6. Preservation of the ICBN is not possible, in the judgement of the attending surgeon (as confirmed in the OR).
• • 7. Anticipated problems with the patient being available for follow-up.
• • 8. Incarceration.
• • 9. The patient is or may be enrolled in a competing trial.
• • 10. 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.