Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05001802
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Techniques of Quadratus Lumborum Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cephalic sensory dermatomal spread', 'timeFrame': '20 minutes after block performance]', 'description': 'The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The most cephalic dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.'}], 'secondaryOutcomes': [{'measure': 'Time to performance of procedure', 'timeFrame': 'Duration of procedure', 'description': 'Duration from needle insertion toward local anesthetic injection finished'}, {'measure': 'Total sensory dermatomal spread', 'timeFrame': '20 minutes after block performance', 'description': 'The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The total number of dermatomal levels that show decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.'}, {'measure': 'Incidence of complication', 'timeFrame': 'Within 48 hours after surgery', 'description': 'incidence of complication including bleeding, hematoma, infection at puncture site, local anesthetic poisoning, etc'}, {'measure': 'Caudal sensory dermatomal spread', 'timeFrame': '20 minutes after block performance', 'description': 'The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The most caudal dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.'}, {'measure': 'rescue analgesics usage', 'timeFrame': 'At 0,12,24,48 hours after surgery', 'description': 'NSAIDs or opioids used for pain relief and their dosage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Block']}, 'descriptionModule': {'briefSummary': 'Our objective is to investigate the extent of cranial dermatomal spread of transmuscular quadratus lumborum block(TMQLB )when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy.', 'detailedDescription': 'The paramedian sagittal oblique transmuscular quadratus lumborum block(TMQLB )approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction compared with the transverse approach. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread level. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥Age 18yrs\n\n * American Society of Anesthesiologists physical status I-II\n * Undergo laparoscopic adrenalectomy\n * Informed consent\n * Able to cooperate with study process\n\nExclusion Criteria:\n\n* Allergy to local anesthetic and other medications used in the study\n* Patient refusal or lack of informed consent\n* Coexisting hematological disorder or with deranged coagulation parameters\n* Pre-existing major organ dysfunction such as hepatic and renal failure\n* History of previous renal surgery.'}, 'identificationModule': {'nctId': 'NCT05001802', 'briefTitle': 'Comparison of Two Techniques of Quadratus Lumborum Block', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Transverse Versus Longitudinal Technique of Ultrasound-Guided Transmuscular Quadratus Lumborum Block:A Randomized Controlled Study Comparing Dermatomal Spread', 'orgStudyIdInfo': {'id': '20210505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transverse quadratus lumborum block', 'description': 'The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.', 'interventionNames': ['Procedure: transverse scan, in-plane, posterior- anterior quadratus lumborum block']}, {'type': 'EXPERIMENTAL', 'label': 'longitudinal quadratus lumborum block', 'description': 'The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.', 'interventionNames': ['Procedure: paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block']}], 'interventions': [{'name': 'transverse scan, in-plane, posterior- anterior quadratus lumborum block', 'type': 'PROCEDURE', 'otherNames': ['drug:ropivacaine'], 'description': 'transverse scan, in-plane, posterior- anterior quadratus lumborum block The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.', 'armGroupLabels': ['transverse quadratus lumborum block']}, {'name': 'paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block', 'type': 'PROCEDURE', 'otherNames': ['drug:ropivacaine'], 'description': 'The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.', 'armGroupLabels': ['longitudinal quadratus lumborum block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'xulei cui, MD.', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xulei cui, MD.', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xulei MD Cui', 'role': 'CONTACT', 'email': 'cuixulei10685@pumch.cn', 'phone': '+8613717739381'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Cui Xulei', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}