RecruitingNCT04014829

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)


Sponsor

KK Women's and Children's Hospital

Enrollment

436 participants

Start Date

Jul 23, 2019

Study Type

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

Sex: FEMALEMin Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at pain after hysterectomy (surgical removal of the uterus) — specifically whether factors like pain sensitivity, fear of movement, and pressure pain thresholds before surgery predict who develops chronic pain afterward. Understanding this may help doctors better prepare and protect patients from long-term pain. **You may be eligible if...** - You are between 21 and 80 years old - You are scheduled for a planned (elective) abdominal or laparoscopic hysterectomy for a benign (non-cancerous) reason - Your general health falls within ASA physical class I to III **You may NOT be eligible if...** - Your hysterectomy is vaginal (rather than abdominal or laparoscopic) - Your main reason for surgery is uterine prolapse, endometriosis, pelvic pain, or cancer - You have a history of drug dependence or recreational drug use - You already have a chronic pain condition - You have a pacemaker or non-sinus heart rhythm that would interfere with pain testing - You take daily corticosteroids (not inhaled) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPain-Pressure Threshold

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.

DIAGNOSTIC_TESTMechanical Temporal Summation

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.

DIAGNOSTIC_TESTHospital Anxiety and Depression Scale

Standardized questionnaire to determine the level of anxiety and depression.

DIAGNOSTIC_TESTPain Catastrophizing Scale

Standardized questionnaire to determine the level of pain catastrophizing.

DIAGNOSTIC_TESTCentral Sensitization Inventory

Standardized questionnaire to determine the level of central sensitization.

DIAGNOSTIC_TESTFear-Avoidance Component Score

Standardized questionnaire to determine the level of fear and avoidance.

DIAGNOSTIC_TESTEQ-5D

Standardized questionnaire to assess generic health-related quality of life.

DIAGNOSTIC_TESTheart rate variability

Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.

DIAGNOSTIC_TESTAnxiety, anticipated pain, anticipated analgesia

Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).

DIAGNOSTIC_TESTState-trait anxiety inventory

Standardized questionnaire to assess anxiety.

DIAGNOSTIC_TESTBeck's Depression Inventory

Standardized questionnaire to assess depressive symptoms.


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

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NCT04014829


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