Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-09 @ 7:37 AM
Study NCT ID:
NCT06507293
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remifentanil consumption', 'timeFrame': 'Intraoperative', 'description': 'Total amount of remifentanil used during the surgery (mg)'}, {'measure': 'NRS Scores', 'timeFrame': 'Postoperative 1st, 6th, 12th and 24th hours', 'description': 'Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)'}, {'measure': 'Morphine consumption', 'timeFrame': 'Postoperative 1st, 6th, 12th and 24th hours', 'description': 'Amount of morphine in the postoperative period (mg)'}], 'secondaryOutcomes': [{'measure': 'Rescue analgesic', 'timeFrame': 'Postoperative 1st, 6th, 12th and 24th hours', 'description': 'The use of rescue analgesic'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'Postoperative 1st, 6th, 12th and 24th hours', 'description': 'If the patient had nausea or vomiting, it will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Opioid Use']}, 'descriptionModule': {'briefSummary': "Thoracotomy is among the most painful surgical procedures and can cause severe pain with a high incidence. Inadequate treatment of acute postoperative pain may lead to undesired complications. Paravertebral block (PVB) is an effective technique that provides adequate analgesia in thoracic surgeries. However, it is an advanced technique with potential complication risks. Erector spinae plane block (ESPB) is a relatively new and considered as a safer technique that provides comparable analgesia. However, the results are controversial and there are few studies that compares the effect of these blocks in thoracic surgeries. As well as the undesired effects of inadequate pain management, high doses of perioperative opioid usage may contribute to the development of dose-dependent long-term adverse events. Hemodynamic parameters are generally used to determine the intraoperative need for opioids in patients; however, hemodynamic parameters are not standardized and they do not provide a clear assessment. The Nociception Level (NoL) index is generated from five different parameters (heart rate, heart Rrate variability, photo-plethysmographic waveform amplitude, skin conductance level, number of skin conductance fluctuations, and their time derivatives) using a finger probe and is a promising monitoring technique. Selecting an effective analgesia method and determining the appropriate dose of opioids using NoL monitoring can reduce perioperative and postoperative complications and shorten hospital stays, allowing patients to return to daily life sooner. Additionally, preventing chronic pain syndromes that may develop in patients with inadequate analgesia, personalizing each patient's analgesia level, reducing healthcare costs, and improving quality of life can be achieved. The data from this study can demonstrate the analgesic efficacy of simpler regional anesthesia techniques, contributing to the widespread adoption of regional anesthesia applications, which is a crucial step in multimodal analgesia, thereby ensuring more effective pain management for surgical patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergo elective thoracotomy surgery\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* Spinal deformities\n* BMI\\>35\n* Patiens \\<50 kg\n* Allergies to study medications'}, 'identificationModule': {'nctId': 'NCT06507293', 'briefTitle': 'Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy', 'orgStudyIdInfo': {'id': 'KAD-FR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESP Group', 'description': 'Patients who will receive erector spinae plane block', 'interventionNames': ['Procedure: Erector spiane plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PVB Group', 'description': 'Patients who will receive paravertebral block', 'interventionNames': ['Procedure: Paravertebral block']}], 'interventions': [{'name': 'Paravertebral block', 'type': 'PROCEDURE', 'description': 'Before the general anesthesia induction, paravertebral block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.', 'armGroupLabels': ['PVB Group']}, {'name': 'Erector spiane plane block', 'type': 'PROCEDURE', 'description': 'Before the general anesthesia induction, erector spinae plane block will be performed at T5 with 0.25% bupivacaine (20 mL) using ultrasound.', 'armGroupLabels': ['ESP Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41350', 'city': 'Kocaeli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hadi Ufuk Yörükoğlu, MD', 'role': 'CONTACT', 'email': 'ufukyorukoglu@gmail.com', 'phone': '+905372439215'}], 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'centralContacts': [{'name': 'Hadi Ufuk Yörükoğlu', 'role': 'CONTACT', 'email': 'ufukyorukoglu@gmail.com', 'phone': '+902623038248'}], 'overallOfficials': [{'name': 'Hadi Ufuk Yörükoğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hadi Ufuk Yörükoğlu', 'investigatorAffiliation': 'Kocaeli University'}}}}