Cholecystectomy, LaparoscopicNCT07058194
Effect of Pre- and Postoperative ESP Block on Frontal QRS-T Angle in Laparoscopic Cholecystectomy
A study testing Preoperative Erector Spinae Plane Block, Postoperative Erector Spinae Plane Block and Standard General Anesthesia in people with Cholecystectomy, Laparoscopic and Pain, Postoperative, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Pain, Postoperative, Electrocardiography
- What is being tested?
- Preoperative Erector Spinae Plane Block, Postoperative Erector Spinae Plane Block and Standard General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2025to 29 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study
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.
Read the 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
- Being tested
- Preoperative Erector Spinae Plane Block, Postoperative Erector Spinae Plane Block, Standard General Anesthesia, Bupivacaine
- Keywords
- Erector Spinae Plane Block (ESP block), Frontal QRS-T Angle, Postoperative Pain Control, Cardiac Risk, Ultrasound-guided Nerve Block, QT interval
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Erector Spinae Plane BlockProcedure or surgery
Also called Bilateral ESP Block Before Induction
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.
Postoperative Erector Spinae Plane BlockProcedure or surgery
Also called Bilateral ESP Block After Surgery
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 AnesthesiaProcedure or surgery
Also called Control
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.
BupivacaineDrug
Also called used as part of ESP block interventions
0.25% bupivacaine, 20 mL per side (total 40 mL), administered bilaterally at T7 level under ultrasound guidance as part of ESP block.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Standard General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 hour before surgery to 1 hour after surgery
Secondary outcomes (2)
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.
Measured: From 1 hour before surgery to 1 hour after surgery
Postoperative Pain Intensity Based on Visual Analog Scale (VAS)
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.
Measured: At 2, 6, 12, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start20 Jul 2025
- Primary completion19 Nov 2025
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
- Investigators
- Veli F Pehlivan, Asiss Prof, Principal investigator, Harran University Faculty of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058194
- Sponsor's protocol ID
- Veli Frontal
- Status last verified
- Feb 2026
- First submitted
- 30 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07058194
- Acronym / sponsor ID
- Veli Frontal
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preoperative ESP Block Group | Experimental | Procedure: Preoperative Erector Spinae Plane Block, Procedure: Standard General Anesthesia, Drug: BupivacainePatients 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. |
| Postoperative ESP Block Grou | Experimental | Procedure: Postoperative Erector Spinae Plane Block, Procedure: Standard General Anesthesia, Drug: BupivacainePatients 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. |
| Control Group (No ESP Block) | Active comparator | Procedure: Standard General AnesthesiaPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Erector Spinae Plane BlockAlso: Bilateral ESP Block Before InductionThis 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. | Procedure or surgery | Preoperative ESP Block Group |
| Postoperative Erector Spinae Plane BlockAlso: Bilateral ESP Block After SurgeryPatients 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. | Procedure or surgery | Postoperative ESP Block Grou |
| Standard General AnesthesiaAlso: ControlThis 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. | Procedure or surgery | Control Group (No ESP Block), Postoperative ESP Block Grou, Preoperative ESP Block Group |
| BupivacaineAlso: used as part of ESP block interventions0.25% bupivacaine, 20 mL per side (total 40 mL), administered bilaterally at T7 level under ultrasound guidance as part of ESP block. | Drug | Postoperative ESP Block Grou, Preoperative ESP Block Group |
Primary outcome
Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG
Time frame: From 1 hour before surgery to 1 hour after surgery
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.
2 secondary outcomes
Change in QT Interval (QTc) Pre- and Postoperatively
Time frame: From 1 hour before surgery to 1 hour after surgery
Postoperative Pain Intensity Based on Visual Analog Scale (VAS)
Time frame: At 2, 6, 12, and 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veli F Pehlivan, Asiss Prof principal investigator
Harran University Faculty of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Erector Spinae Plane Block, Postoperative Erector Spinae Plane Block and Standard General Anesthesia in people with Cholecystectomy, Laparoscopic and Pain, Postoperative, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG (time frame: From 1 hour before surgery to 1 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.