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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT Interval (QTc) Pre- and Postoperatively | 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. | From 1 hour before surgery to 1 hour after surgery |
| Postoperative Pain Intensity Based on Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veli F Pehlivan, Asiss Prof | Harran University Faculty of Medicine, Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veli Fahri Pehlivan | Sanliurfa | 63100 | Turkey (Türkiye) |
The study data will not be shared with other researchers. The dataset contains identifiable clinical and ECG data that are not suitable for public sharing under the current data protection regulations.
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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.
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This is an open-label study due to the nature of the ESP block procedure, which prevents blinding of participants and care providers.
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| 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. |
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| 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. |
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| 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. |
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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. |
| At 2, 6, 12, and 24 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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