Evaluating factors related to 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)
This study is trying to find out what factors might lead to chronic pain after a hysterectomy in women, by looking at things like anxiety and how they feel about pain before and after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 436 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04014829 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify clinically relevant factors associated with chronic post-hysterectomy pain (CPHP) by assessing central sensitization, fear-avoidance, and pain-pressure thresholds in patients undergoing elective hysterectomy for benign conditions. The study will recruit 236 participants at KK Hospital in Singapore and evaluate these risk factors preoperatively, with follow-up assessments at 4 and 6 months post-surgery. Additionally, the study will explore the relationship between heart rate variability, anxiety levels, and anticipated pain with postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 to 80 undergoing elective abdominal or laparoscopic hysterectomy for benign gynecological conditions.
Not a fit: Patients with a history of chronic pain syndrome or those undergoing vaginal hysterectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved preoperative assessments and interventions to reduce the risk of chronic pain after hysterectomy.
How similar studies have performed: While the specific combination of factors being studied is novel, previous studies have indicated that central sensitization and fear-avoidance are relevant to chronic pain outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Singapore
- KK Women's and Children's Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Farida Ithnin, MBBS — KK Women's and Children's Hospital
- Study coordinator: Ban Leong Sng, MBBS
- Email: sng.ban.leong@singhealth.com.sg
- Phone: +65 6394 1077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.