Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery

NCT07259057 | Completed

• 1 other identifier: KTU-ESPB-2022-247
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.

Conditions

Postoperative Pain Management; Open-heart Surgery; Median Sternotomy; Erector Spinae Plane Block

Keywords

Erector Spinae Plane Block; Regional Anesthesia; Open-Heart Surgery; Postoperative Pain; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity (NRS Score)

  Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at standardized postoperative time points.

  First 12 hours after extubation (measured at 1, 6, and 12 hours)

Secondary Outcomes (9)

• Time to First Rescue Analgesic Requirement

  Within 48 hours post-extubation

• Total Rescue Analgesic Consumption

  48 hours post-extrubation

• Heart Rate (beats per minute)

  First 24 postoperative hours

• Mobilization Time

  Up to postoperative day 3

• Length of Hospital Stay

  From completion of surgery until hospital discharge, up to 14 days.

Study Arms (2)

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

Patients received bilateral ultrasound-guided erector spinae plane block at the T5 level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected on each side.

Procedure: Erector spinae plane block (ESPB)

Intravenous Opioid Analgesia (Control)

ACTIVE COMPARATOR

Standard intravenous opioid-based analgesia administered without regional block. A fentanyl infusion (0.5 μg/kg/h) was initiated immediately after induction of general anesthesia and continued intraoperatively per institutional protocol.

Drug: Intravenous Opioid Analgesia

Interventions

Erector spinae plane block (ESPB) PROCEDURE

Bilateral ultrasound-guided erector spinae plane block performed at the T5 vertebral level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected between the erector spinae muscle and the transverse process on each side using a high-frequency linear ultrasound probe and a 22-gauge needle.

Erector Spinae Plane Block (ESPB)

Intravenous Opioid Analgesia DRUG

Standard intravenous opioid-based analgesia administered without regional block. Fentanyl infusion (0.5 μg/kg/h) was started after induction and continued intraoperatively according to institutional protocol.

Intravenous Opioid Analgesia (Control)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years
• Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
• ASA physical status II-III
• Provided written informed consent
• BMI \< 35 kg/m²

You may not qualify if:

• Age \<18 or \>75 years
• Known coagulopathy or anticoagulation contraindicating regional block
• Infection or dermatological lesion at the injection site
• Allergy to local anesthetics
• Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
• Significant psychiatric or cognitive disorder preventing cooperation
• Severe arrhythmia or hemodynamic instability prior to surgery
• Local anesthetic toxicity risk factors or anatomic deformity preventing block placement
• Non-elective or emergency cardiac surgery

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Medicine, Farabi Hospital

Trabzon, Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (3)

• Sarica F, Erturk E, Kutanis D, Akdogan A, Senel AC. Comparison of Thoracic Epidural Analgesia and Traditional Intravenous Analgesia With Respect to Postoperative Respiratory Effects in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1800-1805. doi: 10.1053/j.jvca.2020.09.110. Epub 2020 Sep 20.

  PMID: 33059978 RESULT

• Oostvogels L, Weibel S, Meissner M, Kranke P, Meyer-Friessem CH, Pogatzki-Zahn E, Schnabel A. Erector spinae plane block for postoperative pain. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD013763. doi: 10.1002/14651858.CD013763.pub3.

  PMID: 38345071 RESULT

• Shan XS, Liao DW, Guo J, Xia ZY, Lv X, Shen J, Tong JH, Wei FJ, Li XS, Qu XF, Wang XB, Wang YB, Ou SS, Yang YF, Meng L, Liu H, Peng K, Ji FH. Effect of liposomal bupivacaine for preoperative erector spinae plane block on postoperative pain following video-assisted thoracoscopic lung resection: a multicenter, randomized, double-blind, clinical trial. Int J Surg. 2025 Nov 11. doi: 10.1097/JS9.0000000000003956. Online ahead of print.

  PMID: 41217370 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label randomized controlled trial. Neither participants nor care providers nor investigators were blinded to group allocation because the erector spinae plane block procedure is a hands-on regional anesthesia technique that cannot be feasibly masked. Outcome assessors were also not blinded due to the nature of the intervention and perioperative workflow.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Critical Care

Model Details: This study used a parallel-group randomized controlled design in which participants were allocated in a 1:1 ratio to receive either bilateral erector spinae plane block (ESPB) before anesthesia induction or standard intravenous opioid-based analgesia. Both groups were followed concurrently throughout the perioperative and postoperative periods for outcome assessment.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: January 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 20, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)