Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 12:06 PM
Study NCT ID:
NCT05191966
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio.\n\nA nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Patients' satisfaction and quality of pain management", 'timeFrame': 'Postoperative Day 1', 'description': "Patients' satisfaction and quality of pain management will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version"}, {'measure': 'The number of patient required antiemetic', 'timeFrame': 'Postoperative Day 1', 'description': 'The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv will be administered.'}, {'measure': 'Remifentanil consumption during the surgery', 'timeFrame': 'The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 240 min', 'description': 'The total amount of remifentanil consumed will be recorded.'}, {'measure': 'Incidence of complications related to block', 'timeFrame': 'Postoperative 7 days on an average', 'description': 'Complications associated with S-QLB3 and TPVB block (such as visceral organ injury, pneumothorax, retroperitoneal-paravertebral hematoma, lower extremity-quadriceps weakness, vascular puncture, epidural invasion, intrathecal injection and LAST) will be recorded.'}, {'measure': 'The incidence of side effects related to opioid use', 'timeFrame': 'Postoperative Day 1', 'description': 'Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression will be recorded.'}, {'measure': 'The number of patient required rescue analgesia', 'timeFrame': 'Postoperative Day 1', 'description': 'The number of patients requiring rescue analgesics will be recorded over 24 hours.'}, {'measure': 'The heart rate measurement', 'timeFrame': 'The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min.', 'description': 'The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.'}, {'measure': 'The mean arterial pressure measurement', 'timeFrame': 'The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min.', 'description': 'The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.'}], 'primaryOutcomes': [{'measure': 'Morphine consumption in the first 24 hours after surgery', 'timeFrame': 'Postoperative Day 1', 'description': 'Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score is above 3 at rest and during activity (coughing and deep breathing).'}], 'secondaryOutcomes': [{'measure': 'Post-operative acute pain', 'timeFrame': 'Postoperative Day 1', 'description': 'Pain status at rest and while activity (coughing and deep breathing) will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Acute Pain Scores', 'Subcostal Anterior Quadratus Lumborum Block', 'Thoracic Paravertebral Block', 'Morphine Consumption'], 'conditions': ['Anesthesia', 'Analgesia', 'Acute Pain', 'Patient Controlled Analgesia']}, 'referencesModule': {'references': [{'pmid': '32753940', 'type': 'BACKGROUND', 'citation': 'Kwak KH, Baek SI, Kim JK, Kim TH, Yeo J. Analgesic Effect of Ultrasound-Guided Preoperative Unilateral Lateral Quadratus Lumborum Block for Laparoscopic Nephrectomy: A Randomized, Double-Blinded, Controlled Trial. J Pain Res. 2020 Jul 3;13:1647-1654. doi: 10.2147/JPR.S257466. eCollection 2020.'}, {'pmid': '33762197', 'type': 'BACKGROUND', 'citation': 'Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.'}, {'pmid': '30659364', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, Ahuja S, DeGrande S, Maheshwari K, Chan V. Subcostal approach to anterior quadratus lumborum block for pain control following open urological procedures. J Anesth. 2019 Feb;33(1):148-154. doi: 10.1007/s00540-018-02605-1. Epub 2019 Jan 18.'}, {'pmid': '31412770', 'type': 'BACKGROUND', 'citation': 'Zhu M, Qi Y, He H, Lou J, Pei Q, Mei Y. Analgesic effect of the ultrasound-guided subcostal approach to transmuscular quadratus lumborum block in patients undergoing laparoscopic nephrectomy: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 14;19(1):154. doi: 10.1186/s12871-019-0825-4.'}, {'pmid': '30688787', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and thoracic paravertebral block (TPVB) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.', 'detailedDescription': 'Laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. Acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. Poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications.\n\nFacial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. Quadratus lumborum (QL) block is a relatively new technique. Subcostal anterior QL block (S-QLB3) involves injection in the plane between the psoas and QL muscles. Thoracic paravertebral block (TPVB) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. It has been used successfully as part of multimodal analgesia in renal surgery.\n\nIn this study, it was aimed to evaluate the effects of S-QLB3 block and TPVB block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy.\n\nPatients will be divided into two groups:\n\nGroup S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.\n\nGroup TPVB: A unilateral TPV block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical)\n\nExclusion Criteria:\n\n* Age \\<18y, \\>70y\n* Obesity (BMI\\> 30 kg / m2)\n* Pregnancy\n* Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)\n* Serious cardiac, hepatic, and cerebrovascular disease\n* Hypersensitivity to local anesthetics or a history of allergy\n* Patients with a history of opioid use longer than four weeks\n* Patients with psychiatric disorders or communication difficulties\n* Patients who do not want to participate\n* Asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea'}, 'identificationModule': {'nctId': 'NCT05191966', 'briefTitle': 'Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Comparison of the Effects of Subcostal Anterior Quadratus Lumborum Block and Thoracic Paravertebral Block on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery', 'orgStudyIdInfo': {'id': 'SAQLB-TPVB21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group S-QLB3', 'description': 'S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA', 'interventionNames': ['Procedure: Subcostal Anterior Quadratus Lumborum Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group TPVB', 'description': 'TPVB block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA', 'interventionNames': ['Procedure: Thoracic Paravertebral Block']}], 'interventions': [{'name': 'Subcostal Anterior Quadratus Lumborum Block', 'type': 'PROCEDURE', 'otherNames': ['S-QLB3'], 'description': 'S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM.\n\nIV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.', 'armGroupLabels': ['Group S-QLB3']}, {'name': 'Thoracic Paravertebral Block', 'type': 'PROCEDURE', 'otherNames': ['TPVB'], 'description': 'TPVB block will be performed 30 min. before general anesthesia. TPVB will be performed at T10 transverse process level, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the paravertebral space.\n\nIV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.', 'armGroupLabels': ['Group TPVB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55139', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis Universitesi', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Cengiz KAYA, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Cengiz KAYA', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}