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

NCT07058194 | Completed

• 1 other identifier: Veli Frontal
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy, Laparoscopic; Pain, Postoperative; Electrocardiography; Regional Anesthesia; Cardiac Electrophysiology

Keywords

Erector Spinae Plane Block (ESP block); Frontal QRS-T Angle; Postoperative Pain Control; Cardiac Risk; Ultrasound-guided Nerve Block; QT interval

Outcome Measures

Primary Outcomes (1)

• Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG

  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.

  From 1 hour before surgery to 1 hour after surgery

Secondary Outcomes (2)

• Change in QT Interval (QTc) Pre- and Postoperatively

  From 1 hour before surgery to 1 hour after surgery

• Postoperative Pain Intensity Based on Visual Analog Scale (VAS)

  At 2, 6, 12, and 24 hours postoperatively

Study Arms (3)

Preoperative ESP Block Group

EXPERIMENTAL

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.

Procedure: Preoperative Erector Spinae Plane Block; Procedure: Standard General Anesthesia; Drug: Bupivacaine

Postoperative ESP Block Grou

EXPERIMENTAL

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.

Procedure: Postoperative Erector Spinae Plane Block; Procedure: Standard General Anesthesia; Drug: Bupivacaine

Control Group (No ESP Block)

ACTIVE COMPARATOR

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.

Procedure: Standard General Anesthesia

Interventions

Preoperative Erector Spinae Plane Block PROCEDURE

This procedure involves bilateral ultrasound-guided erector spinae plane block at the T7 level using 20 mL of 0.25% bupivacaine per side (total 40 mL) before the induction of general anesthesia. The intervention aims to evaluate the effects of preoperative ESP block on changes in frontal QRS-T angle and other ECG-derived cardiac electrophysiological parameters.

Also known as: Bilateral ESP Block Before Induction

Preoperative ESP Block Group

Postoperative Erector Spinae Plane Block PROCEDURE

Patients in this group will undergo standard general anesthesia. At the end of the surgery, bilateral ESP block will be performed under ultrasound guidance at the T7 level using 0.25% bupivacaine (20 mL per side, total 40 mL). The aim is to evaluate the effect of postoperative ESP block on changes in frontal QRS-T angle and other cardiac electrophysiological parameters.

Also known as: Bilateral ESP Block After Surgery

Postoperative ESP Block Grou

Standard General Anesthesia PROCEDURE

This group will receive standard general anesthesia without any additional regional block. ECG data will be collected preoperatively and 1 hour postoperatively to serve as a comparison for electrophysiological changes observed in the intervention groups.

Also known as: Control

Control Group (No ESP Block); Postoperative ESP Block Grou; Preoperative ESP Block Group

Bupivacaine DRUG

0.25% bupivacaine, 20 mL per side (total 40 mL), administered bilaterally at T7 level under ultrasound guidance as part of ESP block.

Also known as: used as part of ESP block interventions

Postoperative ESP Block Grou; Preoperative ESP Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Veli F Pehlivan, Asiss Prof

  Harran University Faculty of Medicine, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study due to the nature of the ESP block procedure, which prevents blinding of participants and care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned into three parallel groups to compare the effects of preoperative and postoperative erector spinae plane block on cardiac electrophysiological parameters.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: July 20, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 29, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)