Heart Rate Variability as a Predictor of Rebound Pain Following Total Knee Arthroplasty

NCT06977191 | Completed

• 1 other identifier: 10.04.2025/ 05-605-03
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Rebound Pain; Total Knee Arthroplasty; Postoperative Pain, Chronic; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative (before spinal anesthesia) to 48 hours postoperative

Secondary Outcomes (1)

• Association Between HRV Parameters and Pain Intensity

  0-48 hours postoperative

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mahmut Tutar, MD

  KONYA CITY HOSPİTAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: May 20, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 25, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)