Clinical trial NCT06977191: Heart Rate Variability as a Predictor of Rebound Pain Following Total Knee Arthroplasty
Official title: The Role of Perioperative Heart Rate Variability in Predicting Rebound Pain After Total Knee Arthroplasty: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rebound Pain
Total Knee Arthroplasty
Postoperative Pain, Chronic
Heart Rate Variability
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Use of anticoagulant therapy or presence of coagulation disorders
* Infection at the proposed injection site
* Emergency (non-elective) surgical procedures

Primary outcomes:
measure: Preoperative LF/HF Ratio as a Predictor of Rebound Pain
timeFrame: Preoperative (before spinal anesthesia) to 48 hours postoperative
Secondary outcomes:
measure: Association Between HRV Parameters and Pain Intensity
timeFrame: 0-48 hours postoperative
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
affiliation: KONYA CITY HOSPİTAL
name: Mahmut Tutar, MD
role: PRINCIPAL_INVESTIGATOR
References: