Rebound PainNCT06977191
Heart Rate Variability as a Predictor of Rebound Pain Following Total Knee Arthroplasty
An observational study of Rebound Pain and Total Knee Arthroplasty, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether heart rate variability (HRV), a marker of autonomic nervous system activity, can predict the occurrence of rebound pain after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rebound Pain, Total Knee Arthroplasty, Postoperative Pain, Chronic
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 25 Dec 2025
- 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: Adult patients aged 18 to 70 years scheduled for elective unilateral total knee arthroplasty under spinal anesthesia at a tertiary care hospital. All participants will receive multimodal analgesia including peripheral nerve blocks as part of standard care.
Who may be able to join
- Age between 18 and 70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective, unilateral total knee arthroplasty under spinal anesthesia
- Planned use of multimodal analgesia including peripheral nerve blocks
- Ability to provide written informed consent
- Ability to understand and complete pain diaries and questionnaires
Who cannot join
- Known allergy to local anesthetics
- Contraindications to regional anesthesia
- Contraindications to spinal anesthesia
- ASA physical status IV or higher
- Pregnancy or breastfeeding
- Neurological or psychiatric disorders impairing ability to participate or report outcomes
Show all 9Show fewer
- Use of anticoagulant therapy or presence of coagulation disorders
- Infection at the proposed injection site
- Emergency (non-elective) surgical procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Perioperative Heart Rate Variability in Predicting Rebound Pain After Total Knee Arthroplasty: A Prospective Observational Study
This study aims to investigate whether heart rate variability (HRV), a marker of autonomic nervous system activity, can predict the occurrence of rebound pain after total knee arthroplasty (TKA). Rebound pain is defined as a sudden and intense pain episode (NRS ≥7) that typically arises after the resolution of peripheral nerve blocks used for postoperative analgesia.
Patients undergoing elective unilateral TKA under spinal anesthesia with peripheral nerve blocks will be included. HRV will be measured both before and after surgery using a chest-worn heart rate monitor. Pain levels, analgesic consumption, sleep quality, and patient satisfaction will also be recorded. The primary goal is to determine whether perioperative HRV values can serve as a predictive biomarker for rebound pain.
Secondary outcomes include the relationship between HRV and pain intensity, opioid use, sleep quality, and length of hospital stay. The findings may contribute to developing individualized pain management strategies for TKA patients.
- Conditions
- Rebound Pain, Total Knee Arthroplasty, Postoperative Pain, Chronic, Heart Rate Variability
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative LF/HF Ratio as a Predictor of Rebound Pain
To determine whether the preoperative low frequency to high frequency (LF/HF) ratio of heart rate variability is associated with the development of rebound pain after peripheral nerve block resolution. Patients will be classified based on the presence or absence of rebound pain (defined as a shift from NRS ≤3 to ≥7), and mean LF/HF ratios will be compared. Predictive capacity will be evaluated using logistic regression and ROC analysis.
Measured: Preoperative (before spinal anesthesia) to 48 hours postoperative
Secondary outcomes (1)
Association Between HRV Parameters and Pain Intensity
Correlation between perioperative HRV values (SDNN, RMSSD, LF/HF) and postoperative pain scores (measured by NRS at 8h, 12h, 16h, 24h, and 48h).
Measured: 0-48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 May 2025
- Primary completion20 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rebound PainStudies 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
- 115 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
- Investigators
- Mahmut Tutar, MD, Principal investigator, KONYA CITY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977191
- Sponsor's protocol ID
- 10.04.2025/ 05-605-03
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared due to institutional policy and patient confidentiality considerations.
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
- The Role of Perioperative Heart Rate Variability in Predicting Rebound Pain After Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06977191
- Acronym / sponsor ID
- 10.04.2025/ 05-605-03
- Conditions
- Rebound Pain, Total Knee Arthroplasty, Postoperative Pain, Chronic, Heart Rate Variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 18 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 study aims to investigate whether heart rate variability (HRV), a marker of autonomic nervous system activity, can predict the occurrence of rebound pain after total knee arthroplasty (TKA). Rebound pain is defined as a sudden and intense pain episode (NRS ≥7) that typically arises after the resolution of peripheral nerve blocks used for postoperative analgesia.
Patients undergoing elective unilateral TKA under spinal anesthesia with peripheral nerve blocks will be included. HRV will be measured both before and after surgery using a chest-worn heart rate monitor. Pain levels, analgesic consumption, sleep quality, and patient satisfaction will also be recorded. The primary goal is to determine whether perioperative HRV values can serve as a predictive biomarker for rebound pain.
Secondary outcomes include the relationship between HRV and pain intensity, opioid use, sleep quality, and length of hospital stay. The findings may contribute to developing individualized pain management strategies for TKA patients.
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
- Adult patients aged 18 to 70 years scheduled for elective unilateral total knee arthroplasty under spinal anesthesia at a tertiary care hospital. All participants will receive multimodal analgesia including peripheral nerve blocks as part of standard care.
Key inclusion criteria (6 listed)
- Age between 18 and 70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective, unilateral total knee arthroplasty under spinal anesthesia
- Planned use of multimodal analgesia including peripheral nerve blocks
- Ability to provide written informed consent
Key exclusion criteria (9 listed)
- Known allergy to local anesthetics
- Contraindications to regional anesthesia
- Contraindications to spinal anesthesia
- ASA physical status IV or higher
- Pregnancy or breastfeeding
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
Preoperative LF/HF Ratio as a Predictor of Rebound Pain
Time frame: Preoperative (before spinal anesthesia) to 48 hours postoperative
To determine whether the preoperative low frequency to high frequency (LF/HF) ratio of heart rate variability is associated with the development of rebound pain after peripheral nerve block resolution. Patients will be classified based on the presence or absence of rebound pain (defined as a shift from NRS ≤3 to ≥7), and mean LF/HF ratios will be compared. Predictive capacity will be evaluated using logistic regression and ROC analysis.
1 secondary outcome
Association Between HRV Parameters and Pain Intensity
Time frame: 0-48 hours postoperative
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 20 Aug 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared due to institutional policy and patient confidentiality considerations.
Related trials for Rebound Pain
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Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
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Effect of Local Anesthetic Concentration on Rebound Pain
Rebound Pain, Shoulder Arthroplasty
Not yet recruitingPhase 4
Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.
Acute Pain, Orthopaedic Surgery
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.
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 Rebound Pain and Total Knee Arthroplasty, 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 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?
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?
Preoperative LF/HF Ratio as a Predictor of Rebound Pain (time frame: Preoperative (before spinal anesthesia) to 48 hours postoperative). 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.