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

Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Chronic Pain; Acute Pain; Depression, Anxiety
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast cancer surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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 Names: Pressure pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent pain at 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)	4 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent pain at 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)	6 months after surgery
Maximum Acute post-operative pain score	The maximum number of patient-reported post-operative pain score (Numeric Rating Scale 0 to 100) at 0 - 72 hours	Up to 3 days after surgery
Opioid consumption	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.	Up to 3 days after surgery

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Chronic pain; Breast cancer; Acute Pain
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Depression; Pain, Postoperative; Breast Neoplasms; Chronic Pain; Acute Pain
• Other Study ID Numbers: 2017/2805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No