Comparison of IV Analgesia, Thoracic Epidural Analgesia, and ESP Block for Chronic Pain After Open Heart Surgery (TEA-ESPB-IV)

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

This prospective observational study aims to compare three routinely used postoperative analgesia techniques in patients undergoing open heart surgery: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). The primary objective is to evaluate the impact of these analgesia modalities on the development of chronic postoperative pain at 3 months. Secondary objectives include assessing postoperative acute pain scores, additional analgesic requirements, extubation time, mobilization time, intensive care unit stay, hospital stay, respiratory complications, and the relationship between acute and chronic pain. No intervention is assigned by protocol, and all analgesia methods are applied as part of routine clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Postoperative Analgesia; Chronic Postoperative Pain; Open Heart Surgery
• Intervention / Treatment: Other: Intravenous Analgesia; Other: Thoracic Epidural Analgesia (TEA); Other: Erector Spinae Plane Block (ESPB)

Detailed Description

This prospective observational study is designed to evaluate and compare three commonly used postoperative analgesia modalities in adult patients undergoing open heart surgery through median sternotomy: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). All analgesia techniques included in this study represent routine clinical practices performed by the anesthesia team, and no intervention is assigned according to a research protocol. Patients receive whichever analgesia method is chosen by the clinical anesthesia team based on individual clinical conditions. Thus, the study reflects real-world practice in a single tertiary cardiac surgery center.

The primary objective is to determine the effect of these analgesia methods on the development of chronic postoperative pain at 3 months following surgery. Chronic pain will be assessed using the Numeric Rating Scale (NRS) and the S-LANSS questionnaire, administered either via telephone or in-person follow-up. Secondary objectives include the evaluation of postoperative acute pain scores, additional analgesic consumption, extubation time, mobilization time, intensive care unit (ICU) length of stay, hospital length of stay, respiratory parameters, complications such as reintubation or need for non-invasive mechanical ventilation, bronchodilator use, sedation requirements, urine output, and perioperative hemodynamic stability. The study also aims to analyze the correlation between acute postoperative pain and subsequent chronic pain development.

Eligible patients are those aged 18-85 years, classified as ASA I-III, with a body mass index (BMI) below 35 kg/m², and scheduled for open heart surgery at Karadeniz Technical University Farabi Hospital. Exclusion criteria include coagulation disorders, infection at the intervention site, psychiatric disorders, chronic pain treatment, allergy to anesthetic agents, inability to cooperate or communicate, prior open heart surgery, chronic analgesic or antidepressant use, and significant comorbid conditions affecting participation.

Patients included in the study will have their perioperative data extracted from anesthesia records, ICU follow-up forms, and hospital medical charts. Routine postoperative pain measurements will be performed using the NRS. No additional procedures, medications, or interventions beyond routine care will be conducted.

The study aims to enroll 90 patients (30 per group). Data will be analyzed using Statistical Package for the Social Sciences (SPSS). Normality will be assessed using the Kolmogorov-Smirnov test. Parametric and nonparametric tests, including Student's t-test, Mann-Whitney U, chi-square test, repeated-measures ANOVA, and Friedman test, will be used as appropriate. A significance level of p < 0.05 will be accepted.

This study is expected to contribute to the understanding of analgesic strategies in cardiac surgery and their role in preventing chronic postoperative pain, improving recovery, and reducing complications.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Ali AKDOGAN, MD; Phone Number: +905322605414; Email: draliakdogan@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Trabzon
    • Trabzon, Trabzon, Turkey (Türkiye)
      • Recruiting
      • Karadeniz Technical University Farabi Hospital
      • Contact: Ali Akdoğan; Phone Number: 05322605414; Email: draliakdogan@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 85 years who are scheduled to undergo open heart surgery with median sternotomy at Karadeniz Technical University Farabi Hospital. All participants will receive one of the routinely used postoperative analgesia methods (intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block) as determined by the clinical anesthesia team. Only patients classified as ASA physical status I-III and able to provide informed consent are included. Individuals with major comorbidities that interfere with participation, prior cardiac surgery, chronic pain treatment, or contraindications to routine analgesia methods are excluded.

Description

Inclusion Criteria:

• Adults aged 18 to 85 years
• Classified as ASA physical status I-III
• Scheduled to undergo open heart surgery with median sternotomy
• BMI < 35 kg/m²
• Able to understand and provide written informed consent
• Eligible to receive any of the routine analgesia methods (intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block)

Exclusion Criteria:

• Age < 18 or > 85 years
• BMI ≥ 35 kg/m²
• Coagulation disorders
• Infection at the intervention site
• Known allergy to local anesthetics or induction agents
• Psychiatric disorders limiting 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intravenous Analgesia Group (IV); Participants who receive routine postoperative intravenous analgesia (opioid and/or non-opioid medications) as determined by the clinical anesthesia team. No protocol-assigned intervention is applied; analgesia is selected based on routine clinical practice.	Other: Intravenous Analgesia; Routine postoperative intravenous analgesia (opioid and/or non-opioid medications) administered according to standard clinical care. This is not assigned by protocol and represents usual practice.; Other Names: IV Analgesia; Intravenous Pain Management; Other: Thoracic Epidural Analgesia (TEA); Thoracic epidural catheterization performed as part of routine postoperative analgesia management. This practice is determined by the clinical anesthesia team and not assigned by the study protocol.; Other: Erector Spinae Plane Block (ESPB); Bilateral erector spinae plane block performed preoperatively as part of routine perioperative analgesia. The technique is applied at the discretion of the clinical anesthesia team and is not protocol-assigned.
Thoracic Epidural Analgesia Group (TEA); Participants who receive thoracic epidural analgesia via an epidural catheter placed preoperatively for postoperative pain control. TEA is administered according to institutional routine practice and is not assigned by the study protocol	Other: Intravenous Analgesia; Routine postoperative intravenous analgesia (opioid and/or non-opioid medications) administered according to standard clinical care. This is not assigned by protocol and represents usual practice.; Other Names: IV Analgesia; Intravenous Pain Management; Other: Thoracic Epidural Analgesia (TEA); Thoracic epidural catheterization performed as part of routine postoperative analgesia management. This practice is determined by the clinical anesthesia team and not assigned by the study protocol.; Other: Erector Spinae Plane Block (ESPB); Bilateral erector spinae plane block performed preoperatively as part of routine perioperative analgesia. The technique is applied at the discretion of the clinical anesthesia team and is not protocol-assigned.
Erector Spinae Plane Block Group (ESPB); Participants who receive bilateral erector spinae plane block (ESPB) performed preoperatively for postoperative analgesia. This block is a routine clinical procedure and is not assigned or modified by the study protocol.	Other: Intravenous Analgesia; Routine postoperative intravenous analgesia (opioid and/or non-opioid medications) administered according to standard clinical care. This is not assigned by protocol and represents usual practice.; Other Names: IV Analgesia; Intravenous Pain Management; Other: Thoracic Epidural Analgesia (TEA); Thoracic epidural catheterization performed as part of routine postoperative analgesia management. This practice is determined by the clinical anesthesia team and not assigned by the study protocol.; Other: Erector Spinae Plane Block (ESPB); Bilateral erector spinae plane block performed preoperatively as part of routine perioperative analgesia. The technique is applied at the discretion of the clinical anesthesia team and is not protocol-assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Postoperative Pain at 3 Months	Chronic postoperative pain will be assessed 3 months after surgery using the Numeric Rating Scale (NRS, 0-10) and the S-LANSS questionnaire. Participants will be contacted via telephone or in-person follow-up. Chronic pain is defined as pain persisting beyond the expected healing period and lasting at least 3 months.	3 Months Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Postoperative Pain Scores	Pain intensity will be measured using the Numeric Rating Scale (NRS, 0-10) at routine postoperative intervals in the ICU and ward.	0-72 hours postoperative
Additional Analgesic Consumption	Total amount and frequency of rescue analgesic medications administered during the postoperative hospital period.	0-72 hours postoperative
Extubation Time	Time from ICU admission after surgery to successful extubation, recorded from anesthesia and ICU charts.	Up to 72 hours postoperative
Mobilization Time	Time to first mobilization (sitting, standing, or ambulation) recorded by ICU or ward nursing staff.	Postoperative day 0-2
ICU Length of Stay	Duration of ICU stay in hours, extracted from patient records.	Up to 7 days
Hospital Length of Stay	Total hospitalization duration from surgery to discharge.	Up to 14 days
Postoperative Respiratory Events	Incidence of re-intubation, need for non-invasive mechanical ventilation (NIMV), bronchodilator therapy, or respiratory complications.	Up to 14 days postoperative
Correlation Between Acute and Chronic Pain	Correlation analysis between early postoperative pain scores (NRS) and chronic pain severity (NRS + S-LANSS) at 3 months.	From immediate postoperative period to 3-month follow-up

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Publications and helpful links

General Publications

• Yan H, Chen W, Chen Y, Gao H, Fan Y, Feng M, Wang X, Tang H, Yin J, Qian Y, Ding M, Cang J, Miao C, Wang H. Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain After Thoracoscopic Surgery: The Use of Intravenous and Epidural Esketamine. Anesth Analg. 2023 Aug 1;137(2):399-408. doi: 10.1213/ANE.0000000000006547. Epub 2023 Jul 14.
• Yu H, Zheng JQ, Hua YS, Ren SF, Yu H. 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. Trials. 2019 Nov 27;20(1):645. doi: 10.1186/s13063-019-3742-4.
• Martorella G, McDougall GJ Jr. Barriers and Facilitators to the Prevention of Chronic Pain in the Subacute Phase After Cardiac Surgery. Pain Manag Nurs. 2021 Feb;22(1):28-35. doi: 10.1016/j.pmn.2020.09.004. Epub 2020 Nov 11.
• Elsharkawy H, Clark JD, El-Boghdadly K. Evidence for regional anesthesia in preventing chronic postsurgical pain. Reg Anesth Pain Med. 2025 Feb 5;50(2):153-159. doi: 10.1136/rapm-2024-105611.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pain Management; Open Heart Surgery; Cardiac Anesthesia; Chronic Postoperative Pain; Post-Sternotomy Pain; Thoracic Epidural Analgesia (TEA); Erector Spinae Plane Block (ESPB)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Anesthesia and Analgesia; Plant Preparations; Biological Products; Complex Mixtures; Tea; Analgesia
• Other Study ID Numbers: KTU-ANES-CHRONICPAIN-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The study is based on clinical follow-up data collected for a single-center observational thesis project, and no data sharing plan has been established.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No