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

NCT ID: NCT06977191

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmut Tutar, MD

Role: PRINCIPAL_INVESTIGATOR

KONYA CITY HOSPİTAL

Locations

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Konya City Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10.04.2025/ 05-605-03

Identifier Type: -

Identifier Source: org_study_id

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