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Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy

RecruitingNCT04014829
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain in Post-Hysterectomy Patients: A Collaborative Cohort Study (EPOCH - Enhancing Post-operative Outcomes in Chronic Pain After Hysterectomy)
Conditions
Interventions
  • Diagnostic test: Pain-Pressure Threshold
  • Diagnostic test: Mechanical Temporal Summation
  • Diagnostic test: Hospital Anxiety and Depression Scale
  • Diagnostic test: Pain Catastrophizing Scale
  • Diagnostic test: Central Sensitization Inventory
  • Diagnostic test: Fear-Avoidance Component Score
  • Diagnostic test: EQ-5D
  • Diagnostic test: heart rate variability
  • Diagnostic test: Anxiety, anticipated pain, anticipated analgesia
  • Diagnostic test: State-trait anxiety inventory
  • Diagnostic test: Beck's Depression Inventory
Sponsor
KK Women's and Children's Hospital
Start date
2019-07-23
Primary completion
2027-12
Sex
Female
Age range
from 21 Years to 80 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Singapore
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04014829