Comparison of IV Analgesia, Thoracic Epidural Analgesia, and ESP Block for Chronic Pain After Open Heart Surgery
NCT ID: NCT07257744
Last Updated: 2025-12-02
Study Results
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Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2025-02-15
2026-04-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Karadeniz Technical University
OTHER
Responsible Party
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Ali AKDOĞAN
Associate Professor of Anesthesiology and Reanimation
Locations
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Karadeniz Technical University Farabi Hospital
Trabzon, Trabzon, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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KTU-ANES-CHRONICPAIN-2024-01
Identifier Type: -
Identifier Source: org_study_id
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