Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Persistent pain at 4 months after surgery
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Maximum Acute post-operative pain score(Up to 3 days after surgery)
- Persistent pain at 6 months after surgery(6 months after surgery)
- Opioid consumption(Up to 3 days after surgery)