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

NCT07257744 | Recruiting

• 1 other identifier: KTU-ANES-CHRONICPAIN-2024-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Postoperative Pain; Open Heart Surgery; Postoperative Analgesia; Analgesia

Keywords

Open Heart Surgery; Chronic Postoperative Pain; Post-Sternotomy Pain; Thoracic Epidural Analgesia (TEA); Erector Spinae Plane Block (ESPB); Pain Management; Cardiac Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Acute Postoperative Pain Scores

  0-72 hours postoperative

• Additional Analgesic Consumption

  0-72 hours postoperative

• Extubation Time

  Up to 72 hours postoperative

• Mobilization Time

  Postoperative day 0-2

• ICU Length of Stay

  Up to 7 days

Study Arms (3)

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; Other: Thoracic Epidural Analgesia (TEA); Other: Erector Spinae Plane Block (ESPB)

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; Other: Thoracic Epidural Analgesia (TEA); Other: Erector Spinae Plane Block (ESPB)

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; Other: Thoracic Epidural Analgesia (TEA); Other: Erector Spinae Plane Block (ESPB)

Interventions

Intravenous Analgesia OTHER

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.

Also known as: IV Analgesia, Intravenous Pain Management

Erector Spinae Plane Block Group (ESPB); Intravenous Analgesia Group (IV); Thoracic Epidural Analgesia Group (TEA)

Thoracic Epidural Analgesia (TEA) OTHER

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 Group (ESPB); Intravenous Analgesia Group (IV); Thoracic Epidural Analgesia Group (TEA)

Erector Spinae Plane Block (ESPB) OTHER

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); Intravenous Analgesia Group (IV); Thoracic Epidural Analgesia Group (TEA)

Eligibility Criteria

• Age: 18 Years - 85 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 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Farabi Hospital

Trabzon, Trabzon, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 31775854 BACKGROUND

• 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.

  PMID: 33189543 BACKGROUND

• 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.

  PMID: 37267129 BACKGROUND

• 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.

  PMID: 39909548 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesia; Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ali AKDOGAN, MD

CONTACT

+905322605414; draliakdogan@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 2, 2025
• Study Start: February 15, 2025
• Primary Completion: December 20, 2025
• Study Completion: April 20, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)