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Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain (INSPIRE)

Primary Purpose

Post-surgical Pain, Pain, Chronic, Intercostal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ICBN preservation surgery
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-surgical Pain focused on measuring PPSP, ICBN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Juravinski HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - ICBN preservation

Control - Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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: Pain that began after surgery or a tissue trauma is experienced; The pain is in an area of preceding surgery or tissue trauma, The pain has persisted for at least three months after surgery, and The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause.
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.
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
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.

Secondary Outcome Measures

Operative Time
Operative time will be measured from the time of the first incision until the time of closure of the incision.
General physical functioning
Short Form-36 Health Assessment Survey (SF-36) Physical Component Summary score. The range of possible scores goes from 0 (worst possible physical functioning) to 100 (best possible physical functioning)
General Mental functioning
Short Form-36 Health Assessment Survey (SF-36) Mental Component Summary score. The range of possible scores goes from 0 (worst possible mental functioning) to 100 (best possible mental functioning)
Upper limb-specific physical functioning
The Quick-Disability Arm Shoulder Hand Survey (Quick-DASH). An 11-item scale that measures physical function in people with any or multiple musculoskeletal disorders of the upper limb. The range of scores goes from 0 (worst possible functioning) to 100 (best possible functioning).
Return to Work
We will document when participants, who were employed before their surgery, return to work.
Adverse Events
All adverse events will be documented on the study specific case report forms. An independent medical monitor will also review each adverse event to determine its relatedness to the surgical treatment.
Pain Interference
Item PAININ18 of the PROMIS will be used to determine the proportion of patients who report somewhat-to-very much pain interference over 12 months post-surgery. This item is scored from 0 (not at all) to 4 (very much), and we will use a cut-off value of 2 (somewhat) or higher to define an event.
Use of Prescription Opioids
We will capture the proportion of patients who are prescribed an opioid at 3, 6, 9 and 12-months post-surgery, including the type and dose.
Return to household activities
We will document when participants return to their normal household activities.
Return to leisure activities
We will document when participants return to their normal leisure activities.
Return to pre-surgical functioning
We will document when participants achieve 80% of their pre-surgery function, as measured on a percentage scale of 0% (no function) to 100% (full pre-surgical function).

Full Information

First Posted
January 18, 2018
Last Updated
June 24, 2020
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03421522
Brief Title
Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain
Acronym
INSPIRE
Official Title
Intercostobrachial Nerve Sparing in Breast Cancer Surgery to Reduce Persistent Post-surgical Pain - an International Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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 explored the effect of ICBN preservation versus sacrifice during breast cancer surgery. This review found that division of the ICBN was associated with higher risk of sensory deficits, and that nerve preservation techniques increased the median operating time by 5 minutes. Due to limitations of existing evidence, clinical practice guidelines currently provide no recommendations on whether the ICBN should be preserved during axillary lymph node dissection.A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing PPSP after breast cancer surgery involving ALND. If all the apparent effect of axillary dissection is associated with lack of ICBN preservation, the absolute reduction of rates of PPSP would be considerable. Furthermore, nerve sparing requires no specialized equipment, suggesting that scalability will be highly feasible. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Pain, Pain, Chronic, Intercostal Pain, Breast Cancer
Keywords
PPSP, ICBN

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention - ICBN preservation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICBN preservation surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Persistent post-surgical pain (PPSP)
Description
Post-surgery as defined by the World Health Organization (WHO). The WHO's definition requires 4 criteria for the diagnosis of PPSP: Pain that began after surgery or a tissue trauma is experienced; The pain is in an area of preceding surgery or tissue trauma, The pain has persisted for at least three months after surgery, and The pain is not better explained by an infection, malignancy, a pre-existing pain condition or any other alternative cause.
Time Frame
12 months
Title
Moderate-to-severe PPSP
Description
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.
Time Frame
12 months
Title
Biomarker Sub-Study: Cytokine Levels and PPSP
Description
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
Time Frame
3 weeks, 3 months
Title
Biomarker Sub-Study: Cytokine Levels Pre and Post-Op
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Operative Time
Description
Operative time will be measured from the time of the first incision until the time of closure of the incision.
Time Frame
12 months
Title
General physical functioning
Description
Short Form-36 Health Assessment Survey (SF-36) Physical Component Summary score. The range of possible scores goes from 0 (worst possible physical functioning) to 100 (best possible physical functioning)
Time Frame
12 months
Title
General Mental functioning
Description
Short Form-36 Health Assessment Survey (SF-36) Mental Component Summary score. The range of possible scores goes from 0 (worst possible mental functioning) to 100 (best possible mental functioning)
Time Frame
12 months
Title
Upper limb-specific physical functioning
Description
The Quick-Disability Arm Shoulder Hand Survey (Quick-DASH). An 11-item scale that measures physical function in people with any or multiple musculoskeletal disorders of the upper limb. The range of scores goes from 0 (worst possible functioning) to 100 (best possible functioning).
Time Frame
12 months
Title
Return to Work
Description
We will document when participants, who were employed before their surgery, return to work.
Time Frame
12 months
Title
Adverse Events
Description
All adverse events will be documented on the study specific case report forms. An independent medical monitor will also review each adverse event to determine its relatedness to the surgical treatment.
Time Frame
12 months
Title
Pain Interference
Description
Item PAININ18 of the PROMIS will be used to determine the proportion of patients who report somewhat-to-very much pain interference over 12 months post-surgery. This item is scored from 0 (not at all) to 4 (very much), and we will use a cut-off value of 2 (somewhat) or higher to define an event.
Time Frame
12 months
Title
Use of Prescription Opioids
Description
We will capture the proportion of patients who are prescribed an opioid at 3, 6, 9 and 12-months post-surgery, including the type and dose.
Time Frame
12 months
Title
Return to household activities
Description
We will document when participants return to their normal household activities.
Time Frame
12 months
Title
Return to leisure activities
Description
We will document when participants return to their normal leisure activities.
Time Frame
12 months
Title
Return to pre-surgical functioning
Description
We will document when participants achieve 80% of their pre-surgery function, as measured on a percentage scale of 0% (no function) to 100% (full pre-surgical function).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Pilot Study Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toni Tidy
Phone
905-525-9140
Ext
21737
Email
tonitidy@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Del Fabbro
Email
delfabbg@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Dr Reid
Organizational Affiliation
Hamilton Health Sciences - Juravinski Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Busse
Organizational Affiliation
McMaster Michael DeGroote Centre for National Pain Research and Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila Sprague
Organizational Affiliation
McMaster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Reid, MD
Phone
905-521-2100
Ext
73188
Email
reid@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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http://www.bmj.com/content/355/bmj.i5351
Description
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.
URL
http://janelhanmer.pitt.edu/ProPr.html
Description
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).

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Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain

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