Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-29 @ 9:11 AM
Study NCT ID:
NCT06971432
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2025-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Among the patients planned to undergo elective minimally invasive coronary bypass surgery, those who met the inclusion criteria were divided into two groups using the sealed envelope method by a researcher who would not be involved in any other phase of the study.\n\nAfter intubation and central vein cannulation were performed during the intraoperative period, the block method selected for the patient was applied.\n\nPatient data were recorded during the perioperative period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '48 hours', 'description': 'The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their pain will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the intensity of their pain, and the response will be recorded. A score of 0 indicates no pain, and 10 indicates unbearable, severe pain. Measurements will be taken four times:\n\nT4: 6th hour postoperatively\n\nT5: 12th hour postoperatively\n\nT6: 24th hour postoperatively\n\nT7: 48th hour postoperatively'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '48 hours', 'description': 'ECG monitoring was performed on the patient, and both rhythm and heart rate were observed. Heart rate was recorded as a numeric value per second. Measurements will be taken seven times:\n\nT1: Before induction\n\nT2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow\n\nT3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump\n\nT4: 6th hour postoperatively\n\nT5: 12th hour postoperatively\n\nT6: 24th hour postoperatively\n\nT7: 48th hour postoperatively'}, {'measure': 'Mean Arterial Blood Pressure', 'timeFrame': '48 hours', 'description': 'Intra-arterial cannulation and monitoring were established before induction. Mean arterial blood pressure was measured and recorded in mmHg. Measurements will be taken seven times:\n\nT1: Before induction\n\nT2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow\n\nT3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump\n\nT4: 6th hour postoperatively\n\nT5: 12th hour postoperatively\n\nT6: 24th hour postoperatively\n\nT7: 48th hour postoperatively'}, {'measure': 'Oxygen Saturation', 'timeFrame': '48 hours', 'description': 'Oxygen saturation was measured using a pulse oximeter on the second finger of the hand. It was recorded as a numeric value between 0 and 100. Measurements will be taken seven times:\n\nT1: Before induction\n\nT2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow\n\nT3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump\n\nT4: 6th hour postoperatively\n\nT5: 12th hour postoperatively\n\nT6: 24th hour postoperatively\n\nT7: 48th hour postoperatively'}, {'measure': 'Additional Analgesics', 'timeFrame': '48 hours', 'description': 'It will be assessed whether there is a need for additional analgesics within the first 24 hours. If additional analgesics are required, it will be recorded whether tramadol was administered. If it was, the number of times it was required and the dosage given will be noted. Assessments will be made at the following time points:\n\nT4: 6th hour postoperatively\n\nT5: 12th hour postoperatively\n\nT6: 24th hour postoperatively\n\nT7: 48th hour postoperatively'}, {'measure': 'Nausea', 'timeFrame': '48 hours', 'description': 'The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. The patient will be visited at postoperative hours 6, 12, 24, and 48, and their nausea will be evaluated. The patient will be asked to rate the severity of their nausea on a scale from 0 to 10. A score of 0 indicates no nausea, while 10 indicates severe nausea.'}, {'measure': 'Vomiting', 'timeFrame': '48 hours', 'description': 'The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. The patient will be visited at postoperative hours 6, 12, 24, and 48, and vomiting will be evaluated. If the patient has vomited, the number of episodes will be recorded. The total number of vomiting episodes within 48 hours will be documented.'}, {'measure': 'Itching', 'timeFrame': '48 hours', 'description': 'The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. They will be evaluated at 6, 12, 24, and 48 hours postoperatively and asked whether they are experiencing pruritus. If present, the severity will be rated as mild, moderate, or severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['minimal invasive cardiac surgery'], 'conditions': ['Postoperative Pain', 'Minimal Invasive Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '31417264', 'type': 'RESULT', 'citation': 'Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.'}, {'pmid': '32417925', 'type': 'RESULT', 'citation': 'Ekinci M, Ciftci B, Golboyu BE, Demiraran Y, Bayrak Y, Tulgar S. A Randomized Trial to Compare Serratus Anterior Plane Block and Erector Spinae Plane Block for Pain Management Following Thoracoscopic Surgery. Pain Med. 2020 Jun 1;21(6):1248-1254. doi: 10.1093/pm/pnaa101.'}, {'pmid': '30505564', 'type': 'RESULT', 'citation': 'Thompson C, French DG, Costache I. Pain management within an enhanced recovery program after thoracic surgery. J Thorac Dis. 2018 Nov;10(Suppl 32):S3773-S3780. doi: 10.21037/jtd.2018.09.112.'}, {'pmid': '30340525', 'type': 'RESULT', 'citation': 'Berthoud V, Ellouze O, Nguyen M, Konstantinou M, Aho S, Malapert G, Girard C, Guinot PG, Bouchot O, Bouhemad B. Serratus anterior plane block for minimal invasive heart surgery. BMC Anesthesiol. 2018 Oct 20;18(1):144. doi: 10.1186/s12871-018-0614-5.'}, {'pmid': '37470524', 'type': 'RESULT', 'citation': 'Saikat S, Shweta S, Somalia M, Dibyendu K, Sushan M. Comparative efficacy of serratus anterior plane block (SAPB) and fentanyl for postoperative pain management and stress response in patients undergoing minimally invasive cardiac surgery (MICS). Ann Card Anaesth. 2023 Jul-Sep;26(3):268-273. doi: 10.4103/aca.aca_91_22.'}]}, 'descriptionModule': {'briefSummary': 'A total of 46 patients scheduled to undergo elective coronary artery bypass surgery via a minimally invasive technique will be included in the study. In the preoperative period, patients will be randomly assigned into two groups using the sealed envelope method (SAPB / PECS II).\n\nUpon arrival in the operating room, patients will undergo ECG and SpO₂ monitoring, followed by intra-arterial cannulation for continuous blood pressure monitoring. Anesthesia induction will be performed with 1 mg/kg lidocaine, 2-3 mg/kg propofol, 3 mcg/kg fentanyl, and 0.6 mg/kg rocuronium. Following endotracheal intubation, jugular vein cannulation will be performed.\n\nGroup 1:\n\nDeep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.\n\nGroup 2:\n\nDeep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.\n\nThe following variables will be recorded: patient age, height, body weight, BMI, gender, type of analgesia administered, diagnosis, surgical procedure performed, any complications during or after the procedure, postoperative visual analogue scale (VAS) pain scores, additional postoperative analgesic use, patient satisfaction, postoperative nausea and vomiting, ICU length of stay, and total hospital length of stay.\n\nAll patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.', 'detailedDescription': 'SAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men aged 18-75,\n* ASA I-II-III risk group,\n* Body mass index between 18-35,\n* who will undergo coronary artery bypass surgery with minimally invasive cardiac surgery method\n\nExclusion Criteria:\n\n* Those under 18 and over 75\n* Those with advanced comorbidities\n* Those with ASA score IV\n* Those with a history of bleeding diathesis and those using drugs that cause bleeding disorders\n* Patients with an infection in the area where the block will be performed\n* Patients who are allergic to the local anesthetic agent to be used\n* Patients with a body mass index (BMI) under 18 and over 35 will be excluded from the study.\n\nWithdrawal criteria:\n\n* Patients who want to leave the study group\n* Patients who develop surgical complications will be removed from the study.'}, 'identificationModule': {'nctId': 'NCT06971432', 'acronym': 'MICS', 'briefTitle': 'Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effectiveness of Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter on Postoperative Pain After Minimally Invasive Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SAPB / SAPB + LİA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group SAPB', 'description': 'SAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior.\n\nDeep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.\n\nAll patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.', 'interventionNames': ['Procedure: Group SAPB']}, {'type': 'EXPERIMENTAL', 'label': 'Group SAPB + LIA', 'description': 'SAPB is applied similarly to the other group. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.\n\nAll patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.', 'interventionNames': ['Procedure: Group SAPB + LIA']}], 'interventions': [{'name': 'Group SAPB', 'type': 'PROCEDURE', 'description': 'Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment. All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.', 'armGroupLabels': ['Group SAPB']}, {'name': 'Group SAPB + LIA', 'type': 'PROCEDURE', 'description': 'SAPB is applied similarly to the other group.Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.\n\nAll patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.', 'armGroupLabels': ['Group SAPB + LIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Seda Kurtbeyoğlu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}