Clinical trial · Observational
Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery
Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)
NCT03408717CI-TRIAL-00121101B-CAPPactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Pain | — | UNRESOLVED | — |
| Depression, Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mechanical Temporal Summation assessment | Other | — | UNRESOLVED |
| Pain threshold assessment | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Persistent post surgical pain (PPSP)
- description
- 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.
- interventionNames
- Other: Questionnaires
- Other: Mechanical Temporal Summation assessment
- Other: Pain threshold assessment
Primary outcomes (1)
- measure
- Persistent pain at 4 months after surgery
- timeFrame
- 4 months after surgery
- description
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.