Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chro
Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant fac
| Condition(s) | Hysterectomy, Chronic Pain, Central Sensitisation, Anxiety Depression |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively. === Phase 2 (anticipated start May 2022): In addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated. |
| Who can participate | Inclusion Criteria: * Age 21 to 80 years old * American Society of Anesthesiologists Physical Scale (ASA) I to III * Benign gynaecological indications for hysterectomy * Elective abdominal or laparoscopic hysterectomy Exclusion Criteria: * Vaginal hysterectomy * Uterine prolapse, endometriosis, malignant disease, or pelvic pain as main indication for surgery * History of drug dependence or recreational drug use * History of chronic pain syndrome * Current chronic daily treatment with corticosteroids, excluding inhaled steroids * Allergy to study drugs * Major heart surgery * Heart transplant * Pacemaker inserted * Baseline non-sinus cardiac rhythm |
| Ages | 21 Years to 80 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | KK Women's and Children's Hospital |
| Locations | Singapore, Singapore |
| Start date | 2019-07-23 |
| NCT ID | NCT04014829 |
| Official listing | https://clinicaltrials.gov/study/NCT04014829 |