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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study due to the nature of the ESP block procedure, which prevents blinding of participants and care providers.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG', 'timeFrame': 'From 1 hour before surgery to 1 hour after surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in QT Interval (QTc) Pre- and Postoperatively', 'timeFrame': 'From 1 hour before surgery to 1 hour after surgery', 'description': '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.'}, {'measure': 'Postoperative Pain Intensity Based on Visual Analog Scale (VAS)', 'timeFrame': 'At 2, 6, 12, and 24 hours postoperatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane Block (ESP block)', 'Frontal QRS-T Angle', 'Postoperative Pain Control', 'Cardiac Risk', 'Ultrasound-guided Nerve Block', 'QT interval'], 'conditions': ['Cholecystectomy, Laparoscopic', 'Pain, Postoperative', 'Electrocardiography', 'Regional Anesthesia', 'Cardiac Electrophysiology']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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:\n\nControl group (no ESP block),\n\nPreoperative ESP block group,\n\nPostoperative ESP block group.\n\nBilateral 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-65 years\n* ASA physical status I-II\n* Scheduled for elective laparoscopic cholecystectomy\n* Voluntary written informed consent obtained\n* Normal preoperative 12-lead ECG (no conduction abnormalities or arrhythmias)\n\nExclusion Criteria:\n\n* History of cardiac disease (e.g., arrhythmia, myocardial infarction, heart failure)\n* Current use of medications affecting cardiac conduction (e.g., antiarrhythmics, beta-blockers)\n* Known allergy to local anesthetics\n* Coagulation disorders or current anticoagulant therapy\n* Pregnancy or breastfeeding\n* Local infection or anatomical deformity at the ESP block injection site\n* Patients with psychiatric or neurological disorders impairing cooperation'}, 'identificationModule': {'nctId': 'NCT07058194', 'briefTitle': 'Effect of Pre- and Postoperative ESP Block on Frontal QRS-T Angle in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Harran University'}, 'officialTitle': 'Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Veli Frontal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative ESP Block Group', 'description': '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.', 'interventionNames': ['Procedure: Preoperative Erector Spinae Plane Block', 'Procedure: Standard General Anesthesia', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Postoperative ESP Block Grou', 'description': '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.', 'interventionNames': ['Procedure: Postoperative Erector Spinae Plane Block', 'Procedure: Standard General Anesthesia', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (No ESP Block)', 'description': '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.', 'interventionNames': ['Procedure: Standard General Anesthesia']}], 'interventions': [{'name': 'Preoperative Erector Spinae Plane Block', 'type': 'PROCEDURE', 'otherNames': ['Bilateral ESP Block Before Induction'], 'description': '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.', 'armGroupLabels': ['Preoperative ESP Block Group']}, {'name': 'Postoperative Erector Spinae Plane Block', 'type': 'PROCEDURE', 'otherNames': ['Bilateral ESP Block After Surgery'], 'description': '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.', 'armGroupLabels': ['Postoperative ESP Block Grou']}, {'name': 'Standard General Anesthesia', 'type': 'PROCEDURE', 'otherNames': ['Control'], 'description': '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.', 'armGroupLabels': ['Control Group (No ESP Block)', 'Postoperative ESP Block Grou', 'Preoperative ESP Block Group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['used as part of ESP block interventions'], 'description': '0.25% bupivacaine, 20 mL per side (total 40 mL), administered bilaterally at T7 level under ultrasound guidance as part of ESP block.', 'armGroupLabels': ['Postoperative ESP Block Grou', 'Preoperative ESP Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Sanliurfa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Veli Fahri Pehlivan, Asisst Prof', 'role': 'CONTACT', 'email': 'vfpehlivan@harran.edu.tr', 'phone': '05327696566'}], 'facility': 'Veli Fahri Pehlivan', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}], 'centralContacts': [{'name': 'Veli F Pehlivan, Asiss Prof', 'role': 'CONTACT', 'email': 'vfpehlivan@harran.edu.tr', 'phone': '05327696566'}, {'name': 'Basak pehlivan, Prof Dr', 'role': 'CONTACT', 'email': 'bpehlivan@harran.edu.tr', 'phone': '05054083194'}], 'overallOfficials': [{'name': 'Veli F Pehlivan, Asiss Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harran University Faculty of Medicine, Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harran University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Veli Fahri Pehlivan', 'investigatorAffiliation': 'Harran University'}}}}