Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04036812
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2019-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Superficial Cervical Plexus Block for Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the cumulative consumption of sufentanil by the PCA', 'timeFrame': '24 hours after surgery', 'description': 'the cumulative consumption of sufentanil by the PCA 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Use of analgesics by the PCA after operation', 'timeFrame': 'at 1, 2, 4, 48 hours after surgery.', 'description': 'the cumulative consumption of sufentanil by PCA'}, {'measure': 'Pain severity score', 'timeFrame': 'at 1, 2, 4, 24, 48 hours after surgery', 'description': 'It will be accessed using NRS'}, {'measure': 'Anesthesia recovery quality scoreļ¼', 'timeFrame': 'at 1 hour after surgery', 'description': "It will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale. The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs."}, {'measure': 'Patient analgesic satisfaction', 'timeFrame': 'at 24 hours after surgery', 'description': 'Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plexus Block;Analgesia;Neurosurgery']}, 'referencesModule': {'references': [{'pmid': '35768167', 'type': 'DERIVED', 'citation': 'Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.'}, {'pmid': '32029493', 'type': 'DERIVED', 'citation': 'Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective suboccipital retrosigmoid approach approach craniotomy;\n2. Age between 18 and 65 years;\n3. American Society of Anesthesiologists (ASA) physical status I-III.\n\nExclusion Criteria:\n\n1. The patients or legal clients refuse to provide informed consent;\n2. Local infection;\n3. Preoperative impairment of consciousness and cognitive function;\n4. Uncontrolled hypertension;\n5. Inability to communicate;\n6. Allergies to experimental drugs;\n7. History of drug abuse;\n8. History of chronic headache;\n9. Aphasia and hearing impairment;\n10. Patients undergoing second craniotomy;\n11. Body mass index \\< 18.5 kg/m2 or \\> 35.0 kg/m2;'}, 'identificationModule': {'nctId': 'NCT04036812', 'briefTitle': 'Superficial Cervical Plexus Block for Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-06-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Superficial cervical plexus block group', 'interventionNames': ['Procedure: Superficial cervical plexus block']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'superficial cervical plexus nerve block will be performed under the guidance of ultrasound', 'armGroupLabels': ['Superficial cervical plexus block group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100070', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing TianTan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yuming Peng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tian Tan Hospital, Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}