Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT07058194
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pre- and Postoperative ESP Block on Frontal QRS-T Angle in Laparoscopic Cholecystectomy
Sponsor:
Harran University
Organization:
Study Overview
Official Title:
Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: