Effect of Pre- and Postoperative ESP Block on Frontal QRS-T Angle in Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Regional Anesthesia; Cardiac Electrophysiology; Cholecystectomy, Laparoscopic; Pain, Postoperative; Electrocardiography
• Interventions: Procedure: Preoperative Erector Spinae Plane Block; Procedure: Postoperative Erector Spinae Plane Block; Procedure: Standard General Anesthesia; Drug: Bupivacaine

• Registration Number: NCT07058194
• Lead Sponsor: Harran University

Brief Summary

This study aims to investigate the effects of preoperative and postoperative Erector Spinae Plane (ESP) block on the frontal QRS-T angle, a marker of cardiac electrophysiological instability, in patients undergoing laparoscopic cholecystectomy. A total of 120 patients aged 18-65 with ASA I-II status will be randomized into three groups: Control (no ESP), Preoperative ESP, and Postoperative ESP. Electrocardiograms (ECGs) will be obtained preoperatively and one hour postoperatively to assess changes in QRS-T angle and other repolarization parameters. This randomized controlled trial will help clarify the potential cardiac effects of ESP block depending on its timing and may provide insight into optimizing anesthetic safety in surgical patients.

Detailed Description

Erector Spinae Plane (ESP) block is widely used in laparoscopic surgeries for postoperative pain control due to its simplicity and efficacy. However, its influence on the autonomic nervous system and subsequent cardiovascular effects, including changes in cardiac electrophysiological parameters, remains insufficiently understood. The frontal QRS-T angle has emerged as a novel and reliable ECG-derived marker associated with increased cardiac risk and ventricular repolarization heterogeneity.

This prospective, randomized, controlled, single-center trial aims to evaluate the impact of ESP block timing on the frontal QRS-T angle. A total of 120 adult patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned into three groups:

Control group (no ESP block),

Preoperative ESP block group,

Postoperative ESP block group.

Bilateral ESP blocks will be administered using 0.25% bupivacaine under ultrasound guidance at the T7 level. Standard general anesthesia will be applied to all patients. ECG recordings will be obtained preoperatively and at the first postoperative hour to calculate the frontal QRS-T angle, QT interval, QTc, Tp-e, Tp-e/QT, and Tp-e/QTc ratios.

The primary outcome is the change in the frontal QRS-T angle. Secondary outcomes include pain scores (VAS), analgesic consumption, and other ECG-based repolarization markers. The findings may enhance perioperative cardiac risk stratification and inform decisions on the optimal timing of ESP block administration in surgical patients with potential cardiac vulnerability.

Study Timeline

• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-07-15
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age between 18-65 years
• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy
• Voluntary written informed consent obtained
• Normal preoperative 12-lead ECG (no conduction abnormalities or arrhythmias)

Exclusion Criteria

• History of cardiac disease (e.g., arrhythmia, myocardial infarction, heart failure)
• Current use of medications affecting cardiac conduction (e.g., antiarrhythmics, beta-blockers)
• Known allergy to local anesthetics
• Coagulation disorders or current anticoagulant therapy
• Pregnancy or breastfeeding
• Local infection or anatomical deformity at the ESP block injection site
• Patients with psychiatric or neurological disorders impairing cooperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative ESP Block Group	Preoperative Erector Spinae Plane Block	Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.
Preoperative ESP Block Group	Standard General Anesthesia	Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.
Postoperative ESP Block Grou	Postoperative Erector Spinae Plane Block	Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
Postoperative ESP Block Grou	Standard General Anesthesia	Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
Postoperative ESP Block Grou	Bupivacaine	Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
Control Group (No ESP Block)	Standard General Anesthesia	Patients in the control group will receive standard general anesthesia only, without any regional block. Preoperative and 1-hour postoperative ECGs will be obtained for comparison of electrophysiologic markers such as Frontal QRS-T angle, QT, QTc, Tp-e, and Tp-e/QTc.
Preoperative ESP Block Group	Bupivacaine	Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.

Primary Outcome Measures

Name	Time	Method
Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG	From 1 hour before surgery to 1 hour after surgery	The primary outcome is the change in frontal QRS-T angle measured on 12-lead ECG before surgery (baseline) and 1 hour after laparoscopic cholecystectomy. This angle is a marker of ventricular repolarization heterogeneity and potential cardiac risk.

Secondary Outcome Measures

Name	Time	Method
Change in QT Interval (QTc) Pre- and Postoperatively	From 1 hour before surgery to 1 hour after surgery	The corrected QT interval (QTc) will be measured on 12-lead ECG before and 1 hour after surgery to evaluate changes in ventricular repolarization associated with ESP block.
Postoperative Pain Intensity Based on Visual Analog Scale (VAS)	At 2, 6, 12, and 24 hours postoperatively	Pain intensity will be assessed using the 10 cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at rest and during coughing at 2, 6, 12, and 24 hours postoperatively. Higher scores indicate worse pain.

Trial Locations

Locations (1)

Veli Fahri Pehlivan; 🇹🇷 Şanlıurfa, Turkey