Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

Active, not recruiting

• Conditions: Breast Cancer; Acute Pain; Depression, Anxiety; Chronic Pain
• Interventions: Other: Questionnaires; Other: Mechanical Temporal Summation assessment; Other: Pain threshold assessment

• Registration Number: NCT03408717
• Lead Sponsor: KK Women's and Children's Hospital

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.

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 Timeline

• Study First Submitted: 2017-12-28
• Study Start: 2018-01-03
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persistent post surgical pain (PPSP)	Questionnaires	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.
Persistent post surgical pain (PPSP)	Mechanical Temporal Summation assessment	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.
Persistent post surgical pain (PPSP)	Pain threshold assessment	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.

Primary Outcome Measures

Name	Time	Method
Persistent pain at 4 months after surgery	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

Name	Time	Method
Maximum Acute post-operative pain score	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
Persistent pain at 6 months after surgery	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)
Opioid consumption	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.

Trial Locations

Locations (2)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States