Clinical trial NCT05198622: Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial
Official title: Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Chronic Pain
Intercostobrachial Nerve Injury
Keywords: Chronic Pain
Breast Surgery
Breast Cancer
Intercostobrachial Nerve Injury
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intercostobrachial nerve (ICBN) is a cutaneous nerve that provides sensation to the lateral chest, upper medial arm and axilla. It arises from the second intercostal nerve and leave intercostal space at the level of midaxillary line. It then pierces the serratus anterior muscle and enters axilla. Intercostobrachial nerve is encountered during axillary lymph node dissection (ALND) while mobilizing axillary contents laterally off the chest wall and tends to tether axillary contents to the lateral chest wall. Many surgeons routinely sacrifice it as doing so makes mobilization easier and allow exposure of long thoracic neve. Currently there is no consensus on the usefulness of preserving intercostobrachial nerve.

According to a 2020 systemic review and meta-analysis, prevalence of CPSP/ PPSP following breast cancer surgery ranged from 2% to 78% and pooled prevalence was found to be 35%. Higher prevalence was associated with ALND. Several risk factors have been identified which contribute to the development of PPSP. These include; Preexisting pain, preoperative opioid exposure, genetics, psychological factors such as anxiety, depression or catastrophizing, intensity of acute postoperative pain and nerve injury during surgery.

As a result of nerve injury, damaged and non-damaged nerve fibers start generating action potential spontaneously. These are considered ectopic inputs as they do not arise from peripheral terminals. These inputs lead to the development of central sensitization, which is a state of exaggerated functional response of neurons involved in the pain pathway. This increased sensitization results due to increased membrane excitability, enhanced synaptic efficacy and decreased inhibition.

The aim of the present trial is to investigate the effect of ICBN preservation on chronic/ persistent post surgical pain (CPSP/ PPSP). This will be achieved through a randomized control trial with CPSP/ PPSP as a primary outcome measure. Secondary outcome measures will include Health Related Quality of Life (HRQoL), operating time, lymph node yield, functional status of ipsilateral shoulder, post-operative complications and post-operative use of opioid analgesics.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or above.
* Known cases of invasive breast Cancer.
* Undergoing Axillary Lymph Node Dissection (ALND) alone, ALND with mastectomy or ALND with breast conservation surgery (BCS)
* Capacity to give informed consent

Exclusion Criteria:

* Chronic diseases limiting motion of shoulder such as neuropathies, history of trauma and autoimmune diseases.
* Patients undergoing redo axillary lymph node dissection.
* Patients undergoing bilateral axillary lymph node dissection.
* History of chronic pain lasting more than 3 months. Potential causes include: arthritis, backache, fibromyalgia, Irritable bowel disease, irritable bowel syndrome and different types of headache.
* M1 stage of the TNM staging system at the time of initial diagnosis.

Primary outcomes:
measure: Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
timeFrame: Baseline (Pre-Operatively)
measure: Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
timeFrame: 2 Weeks (Post-Operatively)
measure: Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
timeFrame: 3 Months (Post-Operatively)
measure: Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
timeFrame: 6 Months (Post-Operatively)
Secondary outcomes:
measure: Health Related Quality of Life using Functional Assessment of cancer therapy-Breast form (FACT-B)
timeFrame: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
measure: Functional Status of Ipsilateral Shoulder using Shoulder Pain and Disability Index (SPADI) Questionnaire
timeFrame: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
measure: Operating Time (Minutes)
timeFrame: Intraoperative
measure: Lymph Node Yield
timeFrame: Intraoperative
measure: Post-Operative Complications as per Clavien Dindo Classification (CDC)
timeFrame: From the time of intervention to 30 days (Post-Operatively)
measure: Post-Operative usage of Opioid Analgesics
timeFrame: 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
measure: Adverse Events
timeFrame: From the time of intervention to 6 months (Post-Operatively)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital & Research Centre
state: Punjab
Study officials:
affiliation: Shaukat Khanum Memorial Cancer Hospital & Research Center
name: Dr. Ibtissam Bin Khalid, MBBS
role: PRINCIPAL_INVESTIGATOR
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