Total Knee ArthroplastyNCT06966011
Rebound Pain After Peripheral Nerve Blocks in Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. Rebound pain is defined as a sudden, severe pain (NRS ≥7) emerging after block resolution. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Pain, Rebound Pain
- How many people
- 294 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2025to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 70 years who are scheduled for elective unilateral total knee arthroplasty under spinal anesthesia at a tertiary care hospital. All participants will receive peripheral nerve blocks as part of a standardized multimodal analgesia protocol. Patients must be physically and cognitively able to provide consent and complete a postoperative pain diary. Those with contraindications to regional anesthesia, allergies to local anesthetics, or significant comorbidities (ASA IV and above) will be excluded.
Who may be able to join
- Age between 18 and 70 years
- ASA physical status I to III
- Scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
- Peripheral nerve block (PNB) planned as part of multimodal analgesia
- Ability to understand and provide written informed consent
- Willingness and ability to complete the postoperative pain diary
Who cannot join
- Known allergy or hypersensitivity to local anesthetics
- Contraindication to regional anesthesia
- ASA physical status IV or higher
- Neurological or psychiatric disorders interfering with study participation or pain reporting
- Use of anticoagulants or presence of coagulopathy
- Use of medications that may alter pain perception or rebound pain response
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- Local infection at the block site
- Emergency surgeries
- Inability or unwillingness to complete the postoperative pain diary or follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Management After Total Knee Arthroplasty: Incidence and Outcomes of Rebound Pain
This prospective observational study aims to determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. Rebound pain is defined as a sudden, severe pain (NRS ≥7) emerging after block resolution. Primary outcome is the incidence of rebound pain; secondary outcomes include pain severity, rescue analgesia use, nausea, vomiting, sleep quality, and patient satisfaction.
- Conditions
- Total Knee Arthroplasty, Postoperative Pain, Rebound Pain, Peripheral Nerve Block, Pain Management
- Medical subject headings
- Pain, Postoperative, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Rebound Pain After Peripheral Nerve Block
Rebound pain is defined as a sudden, severe increase in pain occurring after the resolution of peripheral nerve block, typically within 12-24 hours postoperatively. Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). A score of NRS ≥7 will be considered as severe pain. Patients will record pain scores in a pain diary, and incidence will be calculated as the proportion of patients meeting the rebound pain criteria.
Measured: Within 48 hours after surgery
Secondary outcomes (4)
Sleep Quality
Sleep quality will be assessed using a 6-item sleep questionnaire (scored 1-6, where 1 = best and 6 = worst sleep quality), covering the night before surgery and the first 7 nights postoperatively.
Measured: From 1 day before surgery to postoperative day 7
Patient Satisfaction with Pain Management
Patients will rate their satisfaction with postoperative pain control on a 5-point Likert scale (1 = not at all satisfied, 5 = completely satisfied).
Measured: Postoperative day 7 (via telephone follow-up)
Total Rescue Analgesic Consumption
The total dose of rescue opioid analgesics administered within the first 48 hours postoperatively will be recorded in milligrams.
Measured: Within 48 hours after surgery
Time to First Rescue Analgesia
Time elapsed from the end of surgery to the first administration of rescue analgesia will be recorded.
Measured: Within 48 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 posted11 May 2025
- Study start21 May 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966011
- Sponsor's protocol ID
- 2.02.2025-35892
- Status last verified
- Mar 2026
- First submitted
- 2 May 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data due to institutional policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management After Total Knee Arthroplasty: Incidence and Outcomes of Rebound Pain
- ClinicalTrials.gov ID
- NCT06966011
- Acronym / sponsor ID
- 2.02.2025-35892
- Conditions
- Total Knee Arthroplasty, Postoperative Pain, Rebound Pain, Peripheral Nerve Block, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 11 May 2025 (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 determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. Rebound pain is defined as a sudden, severe pain (NRS ≥7) emerging after block resolution. Primary outcome is the incidence of rebound pain; secondary outcomes include pain severity, rescue analgesia use, nausea, vomiting, sleep quality, and patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 70 years who are scheduled for elective unilateral total knee arthroplasty under spinal anesthesia at a tertiary care hospital. All participants will receive peripheral nerve blocks as part of a standardized multimodal analgesia protocol. Patients must be physically and cognitively able to provide consent and complete a postoperative pain diary. Those with contraindications to regional anesthesia, allergies to local anesthetics, or significant comorbidities (ASA IV and above) will be excluded.
Key inclusion criteria (6 listed)
- Age between 18 and 70 years
- ASA physical status I to III
- Scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
- Peripheral nerve block (PNB) planned as part of multimodal analgesia
- Ability to understand and provide written informed consent
Key exclusion criteria (9 listed)
- Known allergy or hypersensitivity to local anesthetics
- Contraindication to regional anesthesia
- ASA physical status IV or higher
- Neurological or psychiatric disorders interfering with study participation or pain reporting
- Use of anticoagulants or presence of coagulopathy
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
Incidence of Rebound Pain After Peripheral Nerve Block
Time frame: Within 48 hours after surgery
Rebound pain is defined as a sudden, severe increase in pain occurring after the resolution of peripheral nerve block, typically within 12-24 hours postoperatively. Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). A score of NRS ≥7 will be considered as severe pain. Patients will record pain scores in a pain diary, and incidence will be calculated as the proportion of patients meeting the rebound pain criteria.
4 secondary outcomes
Sleep Quality
Time frame: From 1 day before surgery to postoperative day 7
Patient Satisfaction with Pain Management
Time frame: Postoperative day 7 (via telephone follow-up)
Total Rescue Analgesic Consumption
Time frame: Within 48 hours after surgery
Time to First Rescue Analgesia
Time frame: Within 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data due to institutional policies and patient confidentiality considerations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Total Knee Arthroplasty and Postoperative 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 9 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: finished, as of the sponsor's last update on 3 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Rebound Pain After Peripheral Nerve Block (time frame: Within 48 hours 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 3 Apr 2026.