Acute Pain, PostoperativeNCT07511985
Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty
An observational study of Acute Pain, Postoperative and Chronic Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Postoperative, Chronic Pain, Arthroplasty, Replacement, Knee
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2026to 12 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing unilateral elective total knee arthroplasty at Konya City Hospital under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mahmut TUTAR
Konya, Meram
Mahmut TUTAR, 05554648908, masatu42@gmail.com
About this study
Official title: 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.
- Keywords
- rebound pain, chronic postsurgical pain, total knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence of Chronic Postsurgical Pain at 3 Months
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.
Measured: 3 months after surgery
Secondary outcomes (2)
Presence of Chronic Postsurgical Pain at 6 Months assessed by Brief Pain Inventory-Short Form (BPI-SF) interference score
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.
Measured: 6 months after surgery
Pain Intensity in the Early Postoperative Period
Pain intensity at rest and during movement will be assessed using the Numeric Rating Scale during the first 72 hours after surgery.
Measured: 0 to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start19 Aug 2026
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
- Investigators
- Mahmut Tutar, MD, Principal investigator, KONYA CITY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511985
- Sponsor's protocol ID
- KONYAEH-RA-TDP-2025-01
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No