Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy
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)
KK Women's and Children's Hospital
436 participants
Jul 23, 2019
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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
Interventions
Performed on bilateral trapezius muscles. Pressure will be applied at 90 degrees downward with an algometer, with the speed of pressure increase approximately 1kgf/s. Upon the sensation of pain, the patient will vocalize or raise her hand to terminate the test, and the highest reading will be recorded (up to maximum 6kgf). If two values are recorded within 0.2kgf of each other, the mean value will be recorded. If two values are greater than 0.2kgf of each other, a third test will be performed and the mean obtained.
Pinprick hyperalgesia will be evoked using a Von Frey filament, applied to the volar aspect of the dominant forearm. Participants will report using the numerical rating scale the intensity of pain from the first stimulus. Subsequently, ten repetitive stimuli one second apart will be applied with the same filament within an area of 1cm diameter of the same forearm. Subjects will report the rate the pain intensity of the tenth stimulus. The magnitude of MTS is calculated as the difference between the last to the first pain scores. The investigators will classify the participants according to "evoked MTS" if the last stimulus is rated higher than the first, or "no MTS" if the last stimulus is rated equal or lower than the first. The research team administering the test will follow a set script.
Standardized questionnaire to determine the level of anxiety and depression.
Standardized questionnaire to determine the level of pain catastrophizing.
Standardized questionnaire to determine the level of central sensitization.
Standardized questionnaire to determine the level of fear and avoidance.
Standardized questionnaire to assess generic health-related quality of life.
Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.
Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).
Standardized questionnaire to assess anxiety.
Standardized questionnaire to assess depressive symptoms.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04014829