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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07511985
- Acronym / sponsor ID
- KONYAEH-RA-TDP-2025-01
- Keywords
- rebound pain, chronic postsurgical pain, total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Pain Intensity in the Early Postoperative Period
Time frame: 0 to 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmut Tutar, MD principal investigator
KONYA CITY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, Postoperative and Chronic Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmut Tutar, MD (+905552723704, masatu42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Chronic Postsurgical Pain at 3 Months (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.