- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511985
Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty
Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty: A Prospective Observational Study
This prospective observational study aims to evaluate whether rebound pain after peripheral nerve block is associated with the development of chronic postsurgical pain following elective total knee arthroplasty. Adult patients undergoing unilateral total knee arthroplasty under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia will be included. No additional intervention, drug administration, or biological sampling will be performed beyond standard clinical care.
Rebound pain will be assessed during the early postoperative period using pain diaries, numeric rating scale pain scores, and analgesic consumption records. Chronic postsurgical pain and related outcomes will be evaluated at postoperative 3 and 6 months using validated instruments assessing pain severity, neuropathic pain features, psychological status, functional outcomes, and health-related quality of life. The primary outcome is the presence of chronic postsurgical pain at 3 months after surgery. Secondary outcomes include chronic pain at 6 months, pain intensity, neuropathic pain characteristics, opioid consumption, rescue analgesic requirements, sleep disturbance, and quality-of-life measures. The study also aims to explore demographic and clinical factors associated with rebound pain and chronic postsurgical pain.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mahmut Tutar, MD
- Phone Number: +905552723704
- Email: masatu42@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- ASA physical status I to III
- Scheduled for unilateral elective total knee arthroplasty
- Planned to undergo spinal anesthesia
- Planned to receive a peripheral nerve block as part of routine multimodal analgesia
- Able to provide informed consent and complete study assessments
Exclusion Criteria:
- Chronic opioid use (60 mg oral morphine equivalent per day or more, or use for 3 months or longer)
- Significant neuropathy or radiculopathy
- Bilateral or two-stage total knee arthroplasty during the same hospitalization
- Contralateral total knee arthroplasty within the previous 6 months
- Severe cognitive impairment or major psychiatric disorder
- Chronic analgesic dependence
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Rebound Pain
Participants with a transition from well-controlled pain (Numeric Rating Scale [NRS] <=3) to severe pain (NRS >=7) within 0 to 48 hours after peripheral nerve block resolution.
|
|
No Rebound Pain
Participants without a transition from well-controlled pain (Numeric Rating Scale [NRS] <=3) to severe pain (NRS >=7) within 0 to 48 hours after peripheral nerve block resolution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Chronic Postsurgical Pain at 3 Months
Time Frame: 3 months after surgery
|
Chronic postsurgical pain will be defined as pain developing or persisting after total knee arthroplasty that is not explained by another cause.
Participants with pain and at least one Brief Pain Inventory-Short Form interference item score of 3 or higher at postoperative month 3 will be considered positive for chronic postsurgical pain.
|
3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity in the Early Postoperative Period
Time Frame: 0 to 72 hours after surgery
|
Pain intensity at rest and during movement will be assessed using the Numeric Rating Scale during the first 72 hours after surgery.
|
0 to 72 hours after surgery
|
|
Presence of Chronic Postsurgical Pain at 6 Months assessed by Brief Pain Inventory-Short Form (BPI-SF) interference score
Time Frame: 6 months after surgery
|
Presence of chronic postsurgical pain at postoperative month 6 will be assessed using the same Brief Pain Inventory-Short Form (BPI-SF)-based study definition applied at month 3: pain not explained by another cause, NRS >0, and at least one BPI-SF interference item score of 3 or higher.
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MAHMUT TUTAR, MD, Konya City Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KONYAEH-RA-TDP-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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