Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-02 @ 12:57 AM
Study NCT ID:
NCT05824832
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized single-blinded clinical trial. 1:1 Randomization with 2 groups.\n\nGroup 1: 50% of participants will receive an Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine during surgery.\n\nGroup 2: 50% of participants will receive an Interscalene block alone during surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine requirement post surgery', 'timeFrame': '24 hours', 'description': 'To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Pain reported via a numeric rating scale (NRS)', 'timeFrame': '48 hours', 'description': 'To measure pain via a numeric rating scale (NRS) immediately after arrival to recovery area from surgery (time: 0hr), and again at 2, 24, and 48 hours.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['buprenorphine', 'clonidine', 'dexamethasone', 'brachial plexus blocks', 'pain', 'shoulder', 'surgery'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.', 'detailedDescription': 'This study will be a prospective randomized single-blinded clinical trial.\n\nPatients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate.\n\nPatients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group\n\nThe null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients undergoing shoulder arthroscopy\n* Patients willing to participate and sign informed consent\n\nExclusion Criteria:\n\n* Severe COPD/other contraindication to general anesthesia\n* Patient with a weight of less than 60 kg\n* Dementia, not alert or oriented to person, place, or time\n* Chronic pain patient with daily opioid use at home.\n* Patient with allergy to local anesthetics\n* Patient refusal\n* Total shoulder arthroplasty\n* Concomitant pain in different area from operative site.\n* Pregnancy\n* Patient with active infection on the injection sites for the blocks\n* Patients unable or willing to understand or comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT05824832', 'briefTitle': 'Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '216009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interscalene block with the addition of buprenorphine, clonidine, dexamethasone', 'description': 'Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected.', 'interventionNames': ['Drug: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene block with buprenorphine alone', 'description': 'Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected.', 'interventionNames': ['Drug: Interscalene block with buprenorphine alone']}], 'interventions': [{'name': 'Interscalene block with the addition of buprenorphine, clonidine, dexamethasone', 'type': 'DRUG', 'otherNames': ['Nerve block with buprenorphine, clonidine, dexamethasone'], 'description': 'Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery', 'armGroupLabels': ['Interscalene block with the addition of buprenorphine, clonidine, dexamethasone']}, {'name': 'Interscalene block with buprenorphine alone', 'type': 'DRUG', 'otherNames': ['Nerve block with buprenorphine alone'], 'description': 'Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery', 'armGroupLabels': ['Interscalene block with buprenorphine alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Fargo', 'role': 'CONTACT', 'email': 'sfargo@luc.edu', 'phone': '708-216-8046'}, {'name': 'Audrice Francois, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'centralContacts': [{'name': 'Susan Fargo', 'role': 'CONTACT', 'email': 'sfargo@luc.edu', 'phone': '708-216-8046'}], 'overallOfficials': [{'name': 'Audrice Francois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Audrice Francois, MD, FASA', 'investigatorAffiliation': 'Loyola University'}}}}