Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery (B-CAPP)

• ClinicalTrials.gov Identifier: NCT03408717
• Recruitment Status: Active, not recruiting
• First Posted: January 24, 2018
• Last Update Posted: March 9, 2022
• Sponsor: KK Women's and Children's Hospital
• Collaborator: Duke University
• Information provided by (Responsible Party): KK Women's and Children's Hospital

Study Description

Brief Summary:

Pre-existing pain and severe postoperative pain are predictors of persistent pain after surgery, but a complete understanding on the development of persistent pain is still lacking. The study aims to identify clinically relevant and genetic risk factors for persistent postsurgical pain that can be reliably distinguished statistically.

Condition or disease	Intervention/treatment
Breast Cancer; Chronic Pain; Acute Pain; Depression, Anxiety	Other: Questionnaires; Other: Mechanical Temporal Summation assessment; Other: Pain threshold assessment

Detailed Description:

The study will focus on: (i) risk factors representing biopsychosocial processes that influence chronic pain, such as pain and psychological vulnerability; (ii) genetic factors relating to mechanistic pathways to persistent pain generation. Patients will be recruited from those undergoing breast cancer surgery at the mentioned site. Pain and anxiety assessment will be conducted via visual analogue scoring, mechanical temporal summation assessment and a series of questionnaires. After the surgery, all patients will be given appropriate analgesia, and the pain score and analgesia usage will be recorded. Phone survey will be conducted 4 and 6 months, respectively, after surgery to determine the outcomes.

Study Design

• Study Type: Observational
• Estimated Enrollment: 220 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)
• Actual Study Start Date: January 3, 2018
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

Persistent post surgical pain (PPSP); Questionnaires, Mechanical Temporal Summation assessment and pain threshold assessment will be assigned to patient. Within this cohort, some patients will have high pain score recorded (persistent pain) during the follow-up evaluations at 4 and 6 months.

Other: Questionnaires; Questionnaires including Pain catastrophizing scale (PCS), Central Sensitisation Inventory (CSI), Coping Strategies Questionnaire-Revised (CSQ-R), Brief Symptom Inventory-18 (BSI-18), Perceived Stress Scale (PSS), EQ-5D-3L and Eysenck Personality Questionnaire (EPQ) will be administered to the patient.; Other: Mechanical Temporal Summation assessment; A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.; Other Name: MTS; Other: Pain threshold assessment; Pressure is applied 90 degree straight down force on the subject's right/left centre of the trapezius muscle using an algometer, with a speed of pressure ~ 1kgf/s. The above procedure is then repeated 3 times at each site (left/right) which is indicated on the pressure mark with each time having the reading recorded. When patient shows no response ≥ 6kgf, the threshold is recorded as 6kgf. The patient upon feeling pain will say stop or raise the hand to terminate the test. The mean value is obtained by averaging the readings and will then be recorded as the threshold estimate.; Other Name: Pressure pain

Outcome Measures

Primary Outcome Measures :

1. Persistent pain at 4 months after surgery [ Time Frame: 4 months after surgery ]

   Persistent pain is defined as having one of the below criteria at 4 months after surgery:

   i) having pain score at rest (Numeric Rating Scale 0 to 100) of 30 or more; or ii) having pain score on movement (Numeric Rating Scale 0 to 100) of 30 or more; or iii) or "yes" to one of the seven questions on the presence of pain in daily life activities (mood, walking, carrying heavy loads, work, relations with people, sleep, enjoyment of life)

Secondary Outcome Measures :

1. Persistent pain at 6 months after surgery [ Time Frame: 6 months after surgery ]

   Persistent pain is defined as having one of the below criteria at 4 months after surgery:

   i) having pain score at rest (Numeric Rating Scale 0 to 100) of 30 or more; or ii) having pain score on movement (Numeric Rating Scale 0 to 100) of 30 or more; or iii) or "yes" to one of the seven questions on the presence of pain in daily life activities (mood, walking, carrying heavy loads, work, relations with people, sleep, enjoyment of life)

2. Maximum Acute post-operative pain score [ Time Frame: Up to 3 days after surgery ]
   The maximum number of patient-reported post-operative pain score (Numeric Rating Scale 0 to 100) at 0 - 72 hours
3. Opioid consumption [ Time Frame: Up to 3 days after surgery ]
   The total opioid consumption (morphine/ fentanyl/ hydromorphone/ oxycodone/ hydrocodone etc) throughout the 72 hours. The opioid consumption will be converted using oral morphine equivalent (OME) conversion calculations.

Biospecimen Retention:   Samples With DNA

DNA will be extracted from venous blood using the Puregene method at the Research Laboratory of the mentioned site. Known functional polymorphisms in Catechol-O-methyltransferase (COMT), Calcium channel, voltage-dependent, gamma subunit (CACNG2) and Sodium Voltage-Gated Channel Alpha Subunit 9 (SCN9A) gene with evidence of associations with depression, pain, stress and anxiety would be determined by the Taqman allelic discrimination assay method. Alleles will be called using the software. Genetic data will be analyzed for association with the presence of persistent pain.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only females who undergo breast surgery will be included in this study.
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast cancer surgery

Criteria

Inclusion Criteria:

• Aged between 21 - 80 year old;
• Healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (ASA 1-3);
• Undergoing breast cancer surgery.

Exclusion Criteria:

• History of intravenous drug or opioid abuse;
• Current chronic daily treatment with corticosteroids (excluding inhaled steroids);
• Previous history of chronic pain syndrome;
• Obstetric patients.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Singapore

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Sponsors and Collaborators

KK Women's and Children's Hospital

Duke University

Investigators

• Principal Investigator: Ban Leong Sng, FANZCA; KK Women's and Children's Hospital
• Principal Investigator: Ashraf Habib, MBBCh, FRCA; Duke University

  Study Documents (Full-Text)

Documents provided by KK Women's and Children's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] January 18, 2020

More Information

• Responsible Party: KK Women's and Children's Hospital
• ClinicalTrials.gov Identifier: NCT03408717
• Other Study ID Numbers: 2017/2805
• First Posted: January 24, 2018
• Last Update Posted: March 9, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KK Women's and Children's Hospital:

Breast cancer; Chronic pain; Acute Pain; Depression; Anxiety

Additional relevant MeSH terms:

Breast Neoplasms; Chronic Pain; Acute Pain; Pain, Postoperative; Depression; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Behavioral Symptoms; Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes