Breast CancerPAINENCT05198622

Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial

A study testing Intercostobrachial Nerve Preserving Axillary Lymph Node Dissection and Intercostobrachial Nerve Sacrificing Axillary Lymph Node Dissection in people with Breast Cancer and Chronic Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Chronic Pain, Intercostobrachial Nerve Injury
What is being tested?: Intercostobrachial Nerve Preserving Axillary Lymph Node Dissection and Intercostobrachial Nerve Sacrificing Axillary Lymph Node Dissection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 1 sitePakistan
Study dates: 30 Jan 2022to 1 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Shaukat Khanum Memorial Cancer Hospital & Research Centre
Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Conditions: Breast Cancer, Chronic Pain, Intercostobrachial Nerve Injury
Being tested: Intercostobrachial Nerve Preserving Axillary Lymph Node Dissection, Intercostobrachial Nerve Sacrificing Axillary Lymph Node Dissection
Keywords: Chronic Pain, Breast Surgery, Breast Cancer, Intercostobrachial Nerve Injury
Medical subject headings: Breast Neoplasms, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intercostobrachial Nerve Preserving Axillary Lymph Node DissectionProcedure or surgery
A single standardized technique will be used in all of the patients. For patients undergoing mastectomy, ALND will be carried out using the incision given for mastectomy. A separate incision may be required for patients undergoing breast conservation surgery. Flaps of skin and subcutaneous tissue will be raised and dissection will be carried out till the edge of pectoralis major muscle. Clavipectoral fascia will be opened to gain access to axillary fat and the nodes. These will be removed en block and the intercostobrachial nerve will be completely preserved during this dissection.
All of the surgeons carrying out the intervention would have completed formal training (Fellowship Level) in breast surgery.
Intercostobrachial Nerve Sacrificing Axillary Lymph Node DissectionProcedure or surgery
A single standardized technique will be used in all of the patients. For patients undergoing mastectomy, ALND will be carried out using the incision given for mastectomy. A separate incision may be required for patients undergoing breast conservation surgery. Flaps of skin and subcutaneous tissue will be raised and dissection will be carried out till the edge of pectoralis major muscle. Clavipectoral fascia will be opened to gain access to axillary fat and the nodes. These will be removed en block and the intercostobrachial nerve will be sacrificed during this dissection.
All of the surgeons carrying out the intervention would have completed formal training (Fellowship Level) in breast surgery.

Study groups in NCT05198622
Study group	Role	What they receive
Intercostobrachial Nerve Preservation Arm	Experimental	Intercostobrachial nerve preserving axillary lymph node dissection will be carried out. Post-operatively, the patients will be monitored in the post anesthesia care unit (PACU). Acute Post-Operative pain will be controlled using a standardized pain management regimen in accordance with World Health Organization (WHO) analgesia ladder. The patients will be discharged from PACU and admitted to surgical ward once numerical rating score (NRI) is below 4. Receives: Procedure: Intercostobrachial Nerve Preserving Axillary Lymph Node Dissection
Intercostobracial Nerve Sacrifice Arm	Active comparator	Intercostobrachial nerve sacrificing axillary lymph node dissection will be carried out. Post-operatively, the patients will be monitored in the post anesthesia care unit (PACU). Acute Post-Operative pain will be controlled using a standardized pain management regimen in accordance with World Health Organization (WHO) analgesia ladder. The patients will be discharged from PACU and admitted to surgical ward once numerical rating score (NRI) is below 4. Receives: Procedure: Intercostobrachial Nerve Sacrificing Axillary Lymph Node Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows:
Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Measured: Baseline (Pre-Operatively)
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows:
Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Measured: 2 Weeks (Post-Operatively)
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows:
Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Measured: 3 Months (Post-Operatively)
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows:
Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Measured: 6 Months (Post-Operatively)

Secondary outcomes (7)

Health Related Quality of Life using Functional Assessment of cancer therapy-Breast form (FACT-B)
FACT-B is a 37 item, validated tool for the measurement of health of health related quality of life (HRQoL). It consists of five subscales: Physical well being, emotional well being, social well being, functional well being and a breast cancer-specific subscale. Items are rated from 0 (not at all) to 4 (very much) and a total score is calculated. The total score ranges from 0-148. Lower score indicates a better health related quality of life.
Recall Period: Last 7 Days
Measured: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Functional Status of Ipsilateral Shoulder using Shoulder Pain and Disability Index (SPADI) Questionnaire
SPADI is a validated tool for the measurement of shoulder pain and disability. It is composed of pain component and functional assessment component. Each item in score component is rated from 0 (no pain) to 10 (worst imaginable pain) whereas items in functional assessment component are rated from 0 (no difficulty) to 10 (so difficult it requires help). The total score is expressed as a percentage. A higher score indicates more disability.
Recall Period: Last 7 Days
Measured: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Operating Time (Minutes)
Operating Time is the time duration from incision to the closure. It will be measured in minutes.
Measured: Intraoperative
Lymph Node Yield
Lymph node yield is the total number of benign or malignant lymph nodes found in the axillary lymph node dissection specimen at the time of histopathological analysis.
Measured: Intraoperative
Post-Operative Complications as per Clavien Dindo Classification (CDC)
Clavien Dindo Classification divides the severity of post-operative complications based on the level of medical intervention needed. CDC is as following:
Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This Grade also includes wound infections opened at the bedside.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for Grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III (a): intervention not under general anesthesia Grade III (b): intervention under general anesthesia Grade IV: Life-threatening complication (including complications of the Central Nervous System) requiring Intermediate Care/Intensive Care Unit management Grade V: Death of a patient
Measured: From the time of intervention to 30 days (Post-Operatively)
Post-Operative usage of Opioid Analgesics
Type of opioid analgesic and prescribed daily dose in the post-operative period
Measured: 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Adverse Events
All adverse events will be documented on case report forms. The data management committee (DMC) will review these adverse events and determine if these are due to the intervention.
Measured: From the time of intervention to 6 months (Post-Operatively)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 20221 Oct 2022

First posted20 Jan 2022
Study start30 Jan 2022
Primary completion1 Oct 2022 (estimated)
Study completion1 Oct 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 182 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05198622
Sponsor's protocol ID: IRB-21-28
Acronym: PAINE
Status last verified: Jan 2022
First submitted: 9 Jan 2022
Last updated: 1 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28.
PubMed 32611524
Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
PubMed 29738328
Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.
PubMed 19712899
Abdullah TI, Iddon J, Barr L, Baildam AD, Bundred NJ. Prospective randomized controlled trial of preservation of the intercostobrachial nerve during axillary node clearance for breast cancer. Br J Surg. 1998 Oct;85(10):1443-5. doi: 10.1046/j.1365-2168.1998.00843.x.
PubMed 9782034
Torresan RZ, Cabello C, Conde DM, Brenelli HB. Impact of the preservation of the intercostobrachial nerve in axillary lymphadenectomy due to breast cancer. Breast J. 2003 Sep-Oct;9(5):389-92. doi: 10.1046/j.1524-4741.2003.09505.x.
PubMed 12968959
Salmon RJ, Ansquer Y, Asselain B. Preservation versus section of intercostal-brachial nerve (IBN) in axillary dissection for breast cancer--a prospective randomized trial. Eur J Surg Oncol. 1998 Jun;24(3):158-61. doi: 10.1016/s0748-7983(98)92793-7.
PubMed 9630850
Kaur N, Kumar R, Jain A, Saxena AK. Sensory Changes and Postmastectomy Pain Following Preservation of Intercostobrachial Nerve in Breast Cancer Surgery: a Prospective Randomized Study. Indian J Surg Oncol. 2021 Mar;12(1):108-113. doi: 10.1007/s13193-020-01193-5. Epub 2020 Sep 5.
PubMed 33814840
Taira N, Shimozuma K, Ohsumi S, Kuroi K, Shiroiwa T, Watanabe T, Saito M. Impact of preservation of the intercostobrachial nerve during axillary dissection on sensory change and health-related quality of life 2 years after breast cancer surgery. Breast Cancer. 2014 Mar;21(2):183-90. doi: 10.1007/s12282-012-0374-x. Epub 2012 Aug 30.
PubMed 22932759
Chirappapha P, Arunnart M, Lertsithichai P, Supsamutchai C, Sukarayothin T, Leesombatpaiboon M. Evaluation the effect of preserving intercostobrachial nerve in axillary dissection for breast cancer patient. Gland Surg. 2019 Dec;8(6):599-608. doi: 10.21037/gs.2019.10.06.
PubMed 32042666
Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
PubMed 15042521
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Can Chronic Post-surgical Pain be Reduced by Preserving Intercostobrachial Nerve During Axillary Lymph Node Dissection? : A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05198622
Acronym / sponsor ID: PAINE / IRB-21-28
Conditions: Breast Cancer, Chronic Pain, Intercostobrachial Nerve Injury
Keywords: Chronic Pain, Breast Surgery, Breast Cancer, Intercostobrachial Nerve Injury
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 182 participants (estimated)
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
Study start: 30 Jan 2022 (actual)
Primary completion: 1 Oct 2022 (estimated)
Study completion: 1 Oct 2022 (estimated)
First posted: 20 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intercostobrachial Nerve Preservation Arm	Experimental	Procedure: Intercostobrachial Nerve Preserving Axillary Lymph Node DissectionIntercostobrachial nerve preserving axillary lymph node dissection will be carried out. Post-operatively, the patients will be monitored in the post anesthesia care unit (PACU). Acute Post-Operative pain will be controlled using a standardized pain management regimen in accordance with World Health Organization (WHO) analgesia ladder. The patients will be discharged from PACU and admitted to surgical ward once numerical rating score (NRI) is below 4.
Intercostobracial Nerve Sacrifice Arm	Active comparator	Procedure: Intercostobrachial Nerve Sacrificing Axillary Lymph Node DissectionIntercostobrachial nerve sacrificing axillary lymph node dissection will be carried out. Post-operatively, the patients will be monitored in the post anesthesia care unit (PACU). Acute Post-Operative pain will be controlled using a standardized pain management regimen in accordance with World Health Organization (WHO) analgesia ladder. The patients will be discharged from PACU and admitted to surgical ward once numerical rating score (NRI) is below 4.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intercostobrachial Nerve Preserving Axillary Lymph Node DissectionA single standardized technique will be used in all of the patients. For patients undergoing mastectomy, ALND will be carried out using the incision given for mastectomy. A separate incision may be required for patients undergoing breast conservation surgery. Flaps of skin and subcutaneous tissue will be raised and dissection will be carried out till the edge of pectoralis major muscle. Clavipectoral fascia will be opened to gain access to axillary fat and the nodes. These will be removed en block and the intercostobrachial nerve will be completely preserved during this dissection. All of the surgeons carrying out the intervention would have completed formal training (Fellowship Level) in breast surgery.	Procedure or surgery	Intercostobrachial Nerve Preservation Arm
Intercostobrachial Nerve Sacrificing Axillary Lymph Node DissectionA single standardized technique will be used in all of the patients. For patients undergoing mastectomy, ALND will be carried out using the incision given for mastectomy. A separate incision may be required for patients undergoing breast conservation surgery. Flaps of skin and subcutaneous tissue will be raised and dissection will be carried out till the edge of pectoralis major muscle. Clavipectoral fascia will be opened to gain access to axillary fat and the nodes. These will be removed en block and the intercostobrachial nerve will be sacrificed during this dissection. All of the surgeons carrying out the intervention would have completed formal training (Fellowship Level) in breast surgery.	Procedure or surgery	Intercostobracial Nerve Sacrifice Arm

Primary outcome

Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
Time frame: Baseline (Pre-Operatively)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows: Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
Time frame: 2 Weeks (Post-Operatively)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows: Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
Time frame: 3 Months (Post-Operatively)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows: Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours
Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF)
Time frame: 6 Months (Post-Operatively)
BPI SF is a validated tool for the measurement of chronic pain. It assesses average pain intensity over the past 24 hour period. It defines pain as follows: Mild Pain: Score 1-4 Moderate Pain: Score 5-6 Severe Pain: Score 7-10 Recall Period: Last 24 hours

7 secondary outcomes

Health Related Quality of Life using Functional Assessment of cancer therapy-Breast form (FACT-B)
Time frame: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Functional Status of Ipsilateral Shoulder using Shoulder Pain and Disability Index (SPADI) Questionnaire
Time frame: Baseline (Pre-Operatively), 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Operating Time (Minutes)
Time frame: Intraoperative
Lymph Node Yield
Time frame: Intraoperative
Post-Operative Complications as per Clavien Dindo Classification (CDC)
Time frame: From the time of intervention to 30 days (Post-Operatively)
Post-Operative usage of Opioid Analgesics
Time frame: 2 weeks (Post-Operatively), 3 months (Post-Operatively) and 6 months (Post-Operatively)
Adverse Events
Time frame: From the time of intervention to 6 months (Post-Operatively)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Background: PubMed 32611524Wang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28.
Background: PubMed 29738328Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
Background: PubMed 19712899Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.
Background: PubMed 9782034Abdullah TI, Iddon J, Barr L, Baildam AD, Bundred NJ. Prospective randomized controlled trial of preservation of the intercostobrachial nerve during axillary node clearance for breast cancer. Br J Surg. 1998 Oct;85(10):1443-5. doi: 10.1046/j.1365-2168.1998.00843.x.
Background: PubMed 12968959Torresan RZ, Cabello C, Conde DM, Brenelli HB. Impact of the preservation of the intercostobrachial nerve in axillary lymphadenectomy due to breast cancer. Breast J. 2003 Sep-Oct;9(5):389-92. doi: 10.1046/j.1524-4741.2003.09505.x.
Background: PubMed 9630850Salmon RJ, Ansquer Y, Asselain B. Preservation versus section of intercostal-brachial nerve (IBN) in axillary dissection for breast cancer--a prospective randomized trial. Eur J Surg Oncol. 1998 Jun;24(3):158-61. doi: 10.1016/s0748-7983(98)92793-7.
Background: PubMed 33814840Kaur N, Kumar R, Jain A, Saxena AK. Sensory Changes and Postmastectomy Pain Following Preservation of Intercostobrachial Nerve in Breast Cancer Surgery: a Prospective Randomized Study. Indian J Surg Oncol. 2021 Mar;12(1):108-113. doi: 10.1007/s13193-020-01193-5. Epub 2020 Sep 5.
Background: PubMed 22932759Taira N, Shimozuma K, Ohsumi S, Kuroi K, Shiroiwa T, Watanabe T, Saito M. Impact of preservation of the intercostobrachial nerve during axillary dissection on sensory change and health-related quality of life 2 years after breast cancer surgery. Breast Cancer. 2014 Mar;21(2):183-90. doi: 10.1007/s12282-012-0374-x. Epub 2012 Aug 30.
Background: PubMed 32042666Chirappapha P, Arunnart M, Lertsithichai P, Supsamutchai C, Sukarayothin T, Leesombatpaiboon M. Evaluation the effect of preserving intercostobrachial nerve in axillary dissection for breast cancer patient. Gland Surg. 2019 Dec;8(6):599-608. doi: 10.21037/gs.2019.10.06.
Background: PubMed 15042521Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
Background: PubMed 9060536Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Ibtissam Bin Khalid, MBBS principal investigator

Shaukat Khanum Memorial Cancer Hospital & Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistent Post-Surgical Pain (PPSP) using Brief Pain Inventory-Short Form (BPI SF) (time frame: Baseline (Pre-Operatively)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05198622, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.