Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 2:42 PM
Study NCT ID:
NCT04328558
Status:
WITHDRAWN
Last Update Posted:
2022-04-27
First Post:
2020-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clavipectoral Fascia Plane Block for Clavicle Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. The first group is clavipectoral fascia plane block group. The second one is no intervention control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2020-03-28', 'studyFirstSubmitQcDate': '2020-03-28', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours', 'description': 'The primary aim is to compare postoperative opioid consumption'}], 'secondaryOutcomes': [{'measure': 'Pain scores (Visual analogue scores-VAS)', 'timeFrame': 'Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.', 'description': 'Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clavicle fracture', 'Clavipectoral fascia plane block', 'Postoperative analgesia'], 'conditions': ['Clavicle Injury', 'Clavicle Fracture']}, 'referencesModule': {'references': [{'pmid': '31727320', 'type': 'BACKGROUND', 'citation': 'Atalay YO, Mursel E, Ciftci B, Iptec G. Clavipectoral Fascia Plane Block for Analgesia after Clavicle Surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2019 Dec;66(10):562-563. doi: 10.1016/j.redar.2019.06.006. Epub 2019 Nov 11. No abstract available. English, Spanish.'}, {'pmid': '31377668', 'type': 'BACKGROUND', 'citation': 'Ince I, Kilicaslan A, Roques V, Elsharkawy H, Valdes L. Ultrasound-guided clavipectoral fascial plane block in a patient undergoing clavicular surgery. J Clin Anesth. 2019 Dec;58:125-127. doi: 10.1016/j.jclinane.2019.07.011. Epub 2019 Aug 1. No abstract available.'}, {'pmid': '31732427', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Ishihara T, Hosokawa M, Otake H. RETRACTED: Clavipectoral fascial plane block in a patient with dual antiplatelet therapy undergoing emergent clavicular surgery. J Clin Anesth. 2020 May;61:109648. doi: 10.1016/j.jclinane.2019.109648. Epub 2019 Nov 13. No abstract available.', 'retractions': [{'pmid': '35393209', 'source': 'J Clin Anesth. 2022 Aug;79:110779'}]}]}, 'descriptionModule': {'briefSummary': 'The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block.\n\nThe aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).', 'detailedDescription': 'Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the clavicular site of the pectoralis major muscle. It provides the potential interfascial space between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after clavicle surgery. It is also easy to perform. With this advantage and its analgesic effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus block. However, randomized clinical efficacy trials are needed to investigate the effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification I-II\n* Scheduled for clavicle surgery under general anesthesia\n\nExclusion Criteria:\n\n* history of bleeding diathesis,\n* receiving anticoagulant treatment,\n* known local anesthetics and opioid allergy,\n* infection of the skin at the site of the needle puncture,\n* pregnancy or lactation,\n* patients who do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT04328558', 'briefTitle': 'Clavipectoral Fascia Plane Block for Clavicle Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'The Effectiveness of Clavipectoral Fascia Plane Block for Analgesia After Clavicle Surgery: Randomized, Prospective Study', 'orgStudyIdInfo': {'id': 'Medipol Hospital 10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group CPB = Clavipectoral fascia plane block group', 'description': 'In group CPB, CPB will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third of the clavicle. A 22-gauge block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 20 ml of 0.25% bupivacaine will be injected between these two layers. The local anesthetic spread to medial and lateral third of the clavicle will be seen.', 'interventionNames': ['Other: Clavipectoral fascia plane block group']}, {'type': 'NO_INTERVENTION', 'label': 'Group C = Control group', 'description': 'Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.'}], 'interventions': [{'name': 'Clavipectoral fascia plane block group', 'type': 'OTHER', 'description': 'Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.', 'armGroupLabels': ['Group CPB = Clavipectoral fascia plane block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary researcher', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}