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

NCT ID: NCT07058194

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2025-11-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative ESP Block Group

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.

Group Type: EXPERIMENTAL

Preoperative Erector Spinae Plane Block

Intervention Type: 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.

Standard General Anesthesia

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

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

Postoperative ESP Block Grou

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.

Group Type: EXPERIMENTAL

Postoperative Erector Spinae Plane Block

Intervention Type: 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.

Standard General Anesthesia

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

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

Control Group (No ESP Block)

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.

Group Type: ACTIVE_COMPARATOR

Standard General Anesthesia

Intervention Type: 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.

Interventions

Preoperative Erector Spinae Plane Block

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.

Intervention Type: PROCEDURE

Postoperative Erector Spinae Plane Block

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.

Intervention Type: PROCEDURE

Standard General Anesthesia

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.

Intervention Type: PROCEDURE

Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

Bilateral ESP Block Before Induction; Bilateral ESP Block After Surgery; Control; used as part of ESP block interventions

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harran University

OTHER

Sponsor Role: lead

Responsible Party

Veli Fahri Pehlivan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veli F Pehlivan, Asiss Prof

Role: PRINCIPAL_INVESTIGATOR

Harran University Faculty of Medicine, Department of Anesthesiology

Locations

Veli Fahri Pehlivan

Sanliurfa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Veli F Pehlivan, Asiss Prof

Role: CONTACT

vfpehlivan@harran.edu.tr

05327696566

Basak pehlivan, Prof Dr

Role: CONTACT

bpehlivan@harran.edu.tr

05054083194

Facility Contacts

Veli Fahri Pehlivan, Asisst Prof

Role: primary

vfpehlivan@harran.edu.tr

05327696566

Other Identifiers

Veli Frontal

Identifier Type: -

Identifier Source: org_study_id