Actively Recruiting

Age: 18Years - 85Years
All Genders
ID07257744

A Comparative Evaluation of Intravenous Analgesia, Thoracic Epidural Analgesia, and Erector Spinae Plane Block on Chronic Postoperative Pain Following Open Heart Surgery

Led by Karadeniz Technical University · Updated on 2025-12-02

90

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating and comparing three commonly used methods for managing pain after open heart surgery: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). This prospective observational study focuses on adult patients undergoing open heart surgery through a median sternotomy. The main goal is to understand how these pain relief methods affect the development of chronic pain three months after surgery. Secondary goals include examining acute pain levels, additional pain medication needs, recovery times, hospital stays, respiratory complications, and the connection between acute and chronic pain. Patients receive one of the three analgesia methods as part of routine clinical care, chosen by the anesthesia team based on individual conditions. Intravenous analgesia involves opioid and/or non-opioid medications given postoperatively. TEA is administered via a thoracic epidural catheter placed before surgery. ESPB is applied as a bilateral block before surgery. The study does not assign treatments but observes the outcomes from these routine practices. Participants have their medical and anesthesia records reviewed, including pain scores measured using standard scales during and after hospitalization. Follow-up to assess chronic pain is done at three months either by phone or in person, using questionnaires and pain rating scales. Researchers also track multiple recovery factors such as extubation time, mobilization, ICU and hospital stay duration, respiratory events, and analgesic use. The study aims to enroll 90 patients and analyze data to better understand pain management after cardiac surgery.

CONDITIONS

Brief Title

Comparison of IV Analgesia, Thoracic Epidural Analgesia, and ESP Block for Chronic Pain After Open Heart Surgery

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 85 years
  • Classified as ASA physical status I-III
  • Scheduled to undergo open heart surgery with median sternotomy
  • Body mass index (BMI) less than 35 kg/m²
  • Able to understand and provide written informed consent
  • Eligible to receive routine analgesia methods including intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block
Not Eligible

You will not qualify if you...

  • Age under 18 or over 85 years
  • Body mass index (BMI) 35 kg/m² or higher
  • Coagulation disorders
  • Infection at the site of intervention
  • Known allergy to local anesthetics or induction agents
  • Psychiatric disorders that limit cooperation
  • Use of chronic pain medications, antidepressants, corticosteroids, antiepileptics, or routine analgesics
  • Inability to cooperate, communicate, or follow commands
  • Physical or verbal performance impairment
  • Previous open heart surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Surgery and Immediate Post-operative Care

Duration - Up to 14 days

Participants undergo open heart surgery and receive routine postoperative analgesia as determined by their clinical anesthesia team, including intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block.

Hospital stay with daily assessments up to 14 days postoperative

Post-operative Follow-up

Duration - Up to 14 days

Participants are followed to assess acute postoperative pain, additional analgesic use, extubation time, mobilization, ICU and hospital length of stay, respiratory events, and other clinical parameters.

Daily assessments during hospital stay and ICU up to 7 days

Long-term Monitoring

Duration - 3 months

Participants are monitored to evaluate the development of chronic postoperative pain and its correlation to acute pain, with assessments conducted via telephone or in-person follow-up.

1 to 2 follow-up contacts (telephone or in-person)

Trial Site Locations

Total: 1 location

1

Karadeniz Technical University Farabi Hospital

Trabzon, Trabzon, Turkey (Türkiye)

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Research Team

A

Ali AKDOGAN, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomized controlled trial.

Hong Yu, Jian-Qiao Zheng, Yu-Si Hua...

https://pubmed.ncbi.nlm.nih.gov/31775854

Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain After Thoracoscopic Surgery: The Use of Intravenous and Epidural Esketamine.

Huan Yan, Wannan Chen, Youwen Chen...

https://pubmed.ncbi.nlm.nih.gov/37267129