The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms.
C Richard Chapman, Charles J Vierck
https://pubmed.ncbi.nlm.nih.gov/27908839Actively Recruiting
Age: 21Years - 80Years
FEMALE
Healthy Volunteers
ID04014829
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)
Led by KK Women's and Children's Hospital · Updated on 2024-11-26
436
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating factors that may contribute to chronic post-hysterectomy pain (CPHP), a persistent pain lasting at least three months after hysterectomy surgery for benign conditions. This observational study explores how central sensitization, fear-avoidance behaviors, pain sensitivity, and other factors relate to developing CPHP. The study also looks at heart rate variability, anxiety, anticipated pain, and anticipated pain medicine needs as possible predictors of pain after surgery. Participants will undergo preoperative assessments including questionnaires to measure central sensitization, fear-avoidance, anxiety, depression, and pain catastrophizing. Tests for pain-pressure threshold and mechanical temporal summation will be performed. Heart rate variability will be recorded from a 5-minute ECG. All participants will have elective abdominal or laparoscopic hysterectomy. Follow-up assessments will occur at 24 and 48 hours, and at 4 and 6 months after surgery to monitor pain and related factors. During the study, participants will complete multiple standardized questionnaires and undergo physical tests before surgery. Postoperative follow-ups will assess pain levels and other outcomes. Researchers will analyze the data to find links between preoperative factors and chronic or significant postoperative pain. The primary outcomes include chronic pain at 4 months and significant pain at 24 hours. Safety and quality of life will also be monitored throughout the study, which runs until December 2027.
CONDITIONS
Brief Title
Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy
Who Can Participate
Age: 21Years - 80Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 21 to 80 years old
- Female with benign gynaecological indications for hysterectomy
- Scheduled for elective abdominal or laparoscopic hysterectomy
- Physical status classified as ASA I to III
You will not qualify if you...
- Undergoing vaginal hysterectomy
- Surgery indicated for uterine prolapse, endometriosis, malignant disease, or pelvic pain
- History of drug dependence or recreational drug use
- History of chronic pain syndrome
- Current chronic daily corticosteroid treatment (excluding inhaled steroids)
- Allergy to study drugs
- History of major heart surgery or heart transplant
- Presence of a pacemaker
- Baseline non-sinus cardiac rhythm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 months before surgery
Participants complete preoperative assessments including questionnaires and diagnostic tests to evaluate central sensitization, fear-avoidance, pain-pressure threshold, anxiety, depression, heart rate variability, and other factors related to chronic post-surgical pain.
1 to 2 visits (in-person) depending on assessments needed
Surgery and Immediate Post-operative Assessment
Duration - Surgery day plus 48 hours postoperatively
Participants undergo elective abdominal or laparoscopic hysterectomy followed by assessments of heart rate variability, anxiety, anticipated pain, and analgesia requirement at 24 and 48 hours after surgery.
1 visit on surgery day and 2 follow-up visits within 48 hours post-surgery
Long-term Monitoring
Duration - 4 to 6 months after surgery
Participants are followed up at 4 and 6 months after hysterectomy to assess chronic post-hysterectomy pain and related risk factors.
2 visits (in-person or remote) at 4 and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
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Research Team
B
Ban Leong Sng, MBBS
H
Hon Sen Tan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Incidence and risk factors of chronic pain following hysterectomy among Southern Jiangsu Chinese Women.
Chao Han, Zhijun Ge, Wenjie Jiang...
https://pubmed.ncbi.nlm.nih.gov/28800726Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study.
Patrícia R Pinto, Teresa McIntyre, Cristina Nogueira-Silva...
https://pubmed.ncbi.nlm.nih.gov/23063345Incidence and association factors for the development of chronic post-hysterectomy pain at 4- and 6-month follow-up: a prospective cohort study.
Ban Leong Sng, Yin Ying Ching, Nian-Lin R Han...
https://pubmed.ncbi.nlm.nih.gov/29628772Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis.
C Fingleton, K Smart, N Moloney...
https://pubmed.ncbi.nlm.nih.gov/25749012The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample.
Randy Neblett, Howard Cohen, YunHee Choi...
https://pubmed.ncbi.nlm.nih.gov/23490634The Fear-avoidance Components Scale (FACS): Development and Psychometric Evaluation of a New Measure of Pain-related Fear Avoidance.
Randy Neblett, Tom G Mayer, Meredith M Hartzell...
https://pubmed.ncbi.nlm.nih.gov/26228238Mechanosensitivity before and after hysterectomy: a prospective study on the prediction of acute and chronic postoperative pain.
B Brandsborg, M Dueholm, H Kehlet...
https://pubmed.ncbi.nlm.nih.gov/21890662