Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain

NCT03421522 | Unknown

• 1 other identifier: INSPIRE-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing post-surgical pain after breast cancer surgery. If the effect of ICBN preservation is consistent with observational studies, the absolute reduction of rates of persistent pain would be considerable.The primary objective is to determine the effect of ICBN preservation, versus usual care, on the prevalence and intensity of PPSP at one year after breast cancer surgery involving axillary lymph node dissection (ALND). Within the larger INSPIRE pilot, we will also be conducting a biomarker sub-study. The objectives of the biomarker sub-study are: 1) to determine the association between pro-inflammatory cytokine levels and the presence and intensity of persistent pain at 3 weeks, and 3 months post-surgery, and) 2) to determine the effect of study intervention on the change in cytokine levels (pre-operative to post-operative) in participants who consent to participate in the sub-study.

Conditions

Post-surgical Pain; Pain, Chronic; Intercostal Pain; Breast Cancer

Keywords

PPSP; ICBN

Outcome Measures

Primary Outcomes (4)

• Persistent post-surgical pain (PPSP)

  Post-surgery as defined by the World Health Organization (WHO). The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1. Pain that began after surgery or a tissue trauma is experienced; 2. The pain is in an area of preceding surgery or tissue trauma, 3. The pain has persisted for at least three months after surgery, and 4. The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause.

  12 months

• Moderate-to-severe PPSP

  We will establish the severity of PPSP with an item from the Brief Pain Inventory Short Form (BPI-SF), which asks patients to report their 'average' pain intensity rating in the past 24 hrs, on a scale of 0 (no pain) to 10 (maximum pain). As per the BPI-SF scoring system, we will define moderate-to-severe pain as scores of ≥4 out of 10.

  12 months

• Biomarker Sub-Study: Cytokine Levels and PPSP

  We will determine the correlation between pro-inflammatory cytokine levels and the presence and intensity of persistent pain at 3 weeks, and 3 months post-surgery

  3 weeks, 3 months

• Biomarker Sub-Study: Cytokine Levels Pre and Post-Op

  We will determine the effect of the study intervention on the change in cytokine levels (pre-operative to post-operative) in participants who consent to participate in the sub-study.

  3 weeks

Secondary Outcomes (11)

• Operative Time

  12 months

• General physical functioning

  12 months

• General Mental functioning

  12 months

• Upper limb-specific physical functioning

  12 months

• Return to Work

  12 months

Study Arms (2)

Intervention - ICBN preservation

EXPERIMENTAL

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.

Other: ICBN preservation surgery

Control - Usual Care

NO INTERVENTION

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.

Interventions

ICBN preservation surgery OTHER

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.

Intervention - ICBN preservation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Related Publications (24)

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Related Links

• 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).

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Breast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susan Dr Reid

  Hamilton Health Sciences - Juravinski Hospital

  PRINCIPAL INVESTIGATOR

• Jason Busse

  McMaster Michael DeGroote Centre for National Pain Research and Care

  PRINCIPAL INVESTIGATOR

• Sheila Sprague

  McMaster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni Tidy

CONTACT

905-525-9140; tonitidy@mcmaster.ca

Gina Del Fabbro

CONTACT

delfabbg@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Eligible participants will be randomized to one of two treatment groups: 1) ICBN preservation, or 2) usual surgical technique (ICBN sacrifice). Due to the nature of the intervention, it will not be feasible to blind the treating surgeons or the study personnel. The patients, data analysts, and those interpreting the study results will be blinded to treatment allocation.To ensure concealed allocation, eligible patients will be randomized using the randomization function within the REDCap Cloud electronic data capture system. Treatment allocation will be stratified by clinical site to account for systematic differences in surgeons and peri-operative care. To avoid crossover between treatment allocation, randomization will take place in the operating room after the surgeon has confirmed that the participant is a candidate for ICBN preservation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 5, 2018
• Study Start: October 15, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 26, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)