Clinical Trials Directory

Trials / Completed

CompletedNCT07058194

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

Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
135 (actual)
Sponsor
Harran University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREPreoperative Erector Spinae Plane BlockThis 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.
PROCEDUREPostoperative Erector Spinae Plane BlockPatients 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.
PROCEDUREStandard General AnesthesiaThis 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.
DRUGBupivacaine0.25% bupivacaine, 20 mL per side (total 40 mL), administered bilaterally at T7 level under ultrasound guidance as part of ESP block.

Timeline

Start date
2025-07-20
Primary completion
2025-11-19
Completion
2025-11-29
First posted
2025-07-10
Last updated
2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07058194. Inclusion in this directory is not an endorsement.