Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT06941259
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2025-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-01', 'size': 51511, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-19T05:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The patient will be blind whether they receive local anaesthesia or physiological saline as the nerve block ingredient.\n\nThe care providers will be blind to the solution when they are performing the regional anaesthesia.\n\nThe care providers will be blind when they are monitoring the patient after surgery.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with physiological saline.\n\nGroup B: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with 0.25% bupivacaine.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-04-19', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': '24 hours post-surgery', 'description': 'Determination of the total amount of narcotic painkillers used during this period.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': '24 hours post-surgery', 'description': 'Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.'}, {'measure': 'Secondary Outcome', 'timeFrame': '24 hours post-surgery', 'description': 'Incidence of narcotic-related side effects'}, {'measure': 'Secondary Outcome', 'timeFrame': 'through patient discharge postoperative, an average of 5 days postoperatively', 'description': 'Length of hospital stay'}, {'measure': 'Secondary Outcome', 'timeFrame': '1,3,6,12 hours post-surgery', 'description': 'Determination of the total amount of narcotic painkillers used.'}, {'measure': 'Secondary Outcome', 'timeFrame': '1,3,6,12 hours post-surgery', 'description': 'Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectus sheath block', 'ilioinguinal nerve block', 'hand assisted donor nephrectomy'], 'conditions': ['Regional Anesthesia Morbidity']}, 'referencesModule': {'references': [{'pmid': '38305014', 'type': 'RESULT', 'citation': 'Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2.'}, {'pmid': '36326419', 'type': 'RESULT', 'citation': 'Gunaydin B, Ucar T, Arpali E, Akyollu B, Akinci S, Karatas C, Oztorun K, Kocak B. Hand-assisted laparoscopic donor nephrectomy: 1864 cases in 15 years of experience. Turk J Med Sci. 2022 Aug;52(4):1322-1328. doi: 10.55730/1300-0144.5438. Epub 2022 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is:\n\nDoes combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay?\n\nResearchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption.\n\nParticipants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption.\n\nPossible side effects, complications and length of hospital stay will be noted.', 'detailedDescription': "In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group.\n\nThis method is a widely used comparison method and is used to obtain a double-blind study design."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The donors reviewed by the transplant committee and deemed suitable for nephrectomy.\n* Laparoscopic hand assisted donor nephrectomy operation is planned.\n\nExclusion Criteria:\n\n* Allergy to any of the drugs to be used in treatment\n* Patients using chronic narcotics or narcotic receptor agonists\n* Patients with psychiatric disorders\n* Patients with chronic organ failure\n* Patients without end organ damage\n* The patients who did not give consent\n* Foreign national patients\n* Patients with American Society of Anaesthesiologists (ASA) physical status classification score III and above'}, 'identificationModule': {'nctId': 'NCT06941259', 'briefTitle': 'Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy Patients: A Randomized Controlled Double-Blind Prospective Study', 'orgStudyIdInfo': {'id': '2024.394.IRB1.046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group Sham', 'description': 'After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing only physiological saline.', 'interventionNames': ['Procedure: Rectus sheath and ilioinguinal nerve block with physiological saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Block', 'description': 'After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing 0.25% bupivacaine.', 'interventionNames': ['Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesia']}], 'interventions': [{'name': 'Rectus sheath and ilioinguinal nerve block with physiological saline', 'type': 'PROCEDURE', 'otherNames': ['Group A (Sham)'], 'description': 'Rectus sheath and ilioinguinal nerve block without local anaesthesia', 'armGroupLabels': ['Group Sham']}, {'name': 'Rectus sheath and ilioinguinal nerve block with local anaesthesia', 'type': 'PROCEDURE', 'otherNames': ['Group B (Block)'], 'description': 'Rectus sheath and ilioinguinal nerve block with local anaesthesia', 'armGroupLabels': ['Group Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Zeytinburnu', 'country': 'Turkey (Türkiye)', 'facility': 'Koç University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yasemin Sincer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Koç University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}