Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

436

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.4 years study duration

Study Progress81%

Jul 2019Dec 2027

First Submitted

Initial submission to the registry

July 5, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed

13 days until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected

Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

6.4 years

First QC Date

July 5, 2019

Last Update Submit

November 24, 2024

Conditions

Hysterectomy Chronic Pain Central Sensitisation Anxiety Depression

Keywords

HysterectomyChronic PainFear-AvoidanceCentral SensitizationPain-Pressure ThresholdMechanical Temporal SummationHeart rate variability

Outcome Measures

Primary Outcomes (2)

Chronic Post-Hysterectomy Pain at 4 months
The primary outcome measure is the development of chronic post-hysterectomy pain, which is defined as pain that lasts for at least 3 months around the surgical site, lower abdominal, or pelvic region. This will be determined by phone or online assessment at 4 months after surgery, based on the protocol used by Brandsborg et al and the investigators' previous study.
4 months after hysterectomy
Significant postoperative pain at 24 hours
Numerical pain score (0: no pain; 100: worst pain imaginable) will be assessed at 24 hours after hysterectomy with patient moving from supine to sitting position.
24 hours after hysterectomy

Secondary Outcomes (14)

Central Sensitization Inventory (CSI)
2 months (upon recruitment until before surgery)
Fear Avoidance Components Scale (FACS)
2 months (upon recruitment until before surgery)
Hospital Anxiety and Depression Scale (HADS)
2 months (upon recruitment until before surgery)
Pain Catastrophizing Scale (PCS)
2 months (upon recruitment until before surgery)
Quality of life via EQ-5D
2 months (upon recruitment until before surgery)
+9 more secondary outcomes

Study Arms (4)

Control group for CPHP

Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if no significant pain is noted during the follow up evaluations at 4 and 6 months.

Diagnostic Test: Pain-Pressure ThresholdDiagnostic Test: Mechanical Temporal SummationDiagnostic Test: Hospital Anxiety and Depression ScaleDiagnostic Test: Pain Catastrophizing ScaleDiagnostic Test: Central Sensitization InventoryDiagnostic Test: Fear-Avoidance Component ScoreDiagnostic Test: EQ-5DDiagnostic Test: heart rate variabilityDiagnostic Test: Anxiety, anticipated pain, anticipated analgesiaDiagnostic Test: State-trait anxiety inventoryDiagnostic Test: Beck's Depression Inventory

Chronic Post-Hysterectomy Pain (CPHP)

Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if significant pain is noted during the follow up evaluations at 4 and 6 months.

Control group for significant postoperative pain

Significant postoperative pain

Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if significant pain is noted during the follow up evaluations at 24 and 48 hours.

Interventions

Pain-Pressure ThresholdDIAGNOSTIC_TEST

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.

Also known as: PPT