Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain
NCT ID: NCT03421522
Last Updated: 2020-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-10-15
2020-12-01
Brief Summary
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Detailed Description
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In addition, there is substantial evidence that neuro-inflammation as a result of neural damage leads to peripheral and central changes that can be described as peripheral and central sensitization, leading to PPSP. As such, we will be conducting a biomarker sub-study as part of the pilot program. Identification of biomarkers to correlate with the development of neuropathic pain may facilitate identification of individuals at risk for development of PPSP at an early stage. The INSPIRE trial provides an important opportunity to compare patients before and after nerve injury to further explore the association of persistent pain with cytokine biomarkers. The findings will improve our mechanistic understanding of PPSP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention - ICBN preservation
For participants randomized to the ICBN preserving technique, surgeons will perform axillary dissection in which the second ICBN, just inferior to the axillary vein, will be preserved.
ICBN preservation surgery
For participants randomized to the ICBN preserving technique, surgeons will perform axillary dissection in which the second ICBN, just inferior to the axillary vein, will be preserved. Surgeons will be asked to indicate whether the ICBN nerve was fully preserved, partially preserved, or sacrificed.
All study participants will receive anesthetic management at the discretion of the attending physician, which will be documented.
Control - Usual Care
For participants allocated to the usual surgical care arm, attending surgeons will perform a standard Level 1 and 2 axillary node dissection (sacrifice of the ICBN), either alone or with mastectomy or breast conserving surgery.
No interventions assigned to this group
Interventions
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ICBN preservation surgery
For participants randomized to the ICBN preserving technique, surgeons will perform axillary dissection in which the second ICBN, just inferior to the axillary vein, will be preserved. Surgeons will be asked to indicate whether the ICBN nerve was fully preserved, partially preserved, or sacrificed.
All study participants will receive anesthetic management at the discretion of the attending physician, which will be documented.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Susan Dr Reid
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences - Juravinski Hospital
Jason Busse
Role: PRINCIPAL_INVESTIGATOR
McMaster Michael DeGroote Centre for National Pain Research and Care
Sheila Sprague
Role: PRINCIPAL_INVESTIGATOR
McMaster
Locations
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Juravinski Hospital
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Canadian Cancer Statistics
Breast cancer facts and figures 2013-2014. Atlanta: American Cancer Society; 2013
Visnjevac OM, B. Postmastectomy pain syndrome: an unrecognized annual billion dollar national financial burden. J Pain 2013;14
K. M. Intercostobrachial syndrome after nerve-sparing axillary lymph node dissection. Eur J Cancer. 2014;50:S127.
Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P, 3rd, et al. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. Bmj. 2016;355:i5351.
Hamner J, Dewitt B. The Development of a Preference-based Scoring System for PROMIS (PROPr): A Technical Report v 1.1. \[Internet\] 2017;available from: http://janelhanmer.pitt.edu/documents/technicalreportv1.1.pdf (accessed August 29, 2017).
Other Identifiers
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INSPIRE-001
Identifier Type: -
Identifier Source: org_study_id
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