Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy
Recruiting · NCT04014829 · Observational (researchers observe without assigning treatment) · Lead sponsor: KK Women's and Children's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
2 locations listed.
- KK Women's and Children's Hospital - Singapore, Singapore
- KK Women's and Children's Hospital - Singapore, Singapore