Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-07 @ 5:10 AM
Study NCT ID:
NCT01538459
Status:
WITHDRAWN
Last Update Posted:
2013-05-20
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'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': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.', 'timeFrame': '4 hours', 'description': 'Normal fasting blood glucose is defined by investigators as less than 100mg/dL.(current literature suggests normal is 70-100 so investigators have chosen to utilize high normal.) Any increase greater than 10%(or 10mg/dL ) would be considered a response to the dexamethasone.'}], 'secondaryOutcomes': [{'measure': 'Pain post-operative(immediately)- both at rest and with movement(VAS Scale)', 'timeFrame': '4 hours', 'description': 'Investigators will document patient pain in post-anesthesia care unit (both at rest and with movement)utilizing the VAS scale.'}, {'measure': 'Time until first narcotic usage post operatively', 'timeFrame': '14 days', 'description': 'Patients will be called for follow-up days 1, 2 and 14 and provided with a pain diary to document first narcotic usage.'}, {'measure': 'Block Quality and Duration(time until first motor return)', 'timeFrame': '14 Days', 'description': 'Patients will be called for follow up on days 1, 2 and 14 and provided with a pain diary to document the quality and duration of the motor block.'}, {'measure': 'Block Quality and Duration(time until first sensory return)', 'timeFrame': '14 Days', 'description': 'Patients will be called for follow up on days 1, 2 and 14 and provided with a pain diary to document the quality and duration of the sensory block.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood Glucose', 'Bupivacaine', 'Interscalene Nerve Block', 'Regional Anesthesia', 'Pain Blockade', 'Arthroscopic Surgery', 'Arthroscopic rotator cuff repair', 'Dexamethasone', 'Anti-Inflammatory Agents', 'Therapeutic Uses', 'Physiological Effects of Drugs', 'Glucocorticoids', 'Anesthetics, Local', 'Anesthetics', 'Sensory System Agents', 'Adjuvants, Anesthesia', 'Anesthesiology', 'Injections', 'Adult', 'Analgesia/methods', 'Brachial Plexus/drug effects', 'Brachial Plexus/surgery', 'Brachial Plexus/ultrasonography', 'Bupivacaine/administration & dosage', 'Dexamethasone/administration & dosage', 'Drug Therapy, Combination', 'Female', 'Humans', 'Male', 'Nerve Block/methods', 'Pain, Postoperative/etiology', 'Pain, Postoperative/prevention & control', 'Prospective Studies', 'Time Factors'], 'conditions': ['Shoulder Pain', 'Injury of Shoulder Region', 'Disorder of Shoulder', 'Disorder of Rotator Cuff', 'Disorder of Tendon of Biceps']}, 'referencesModule': {'references': [{'pmid': '21676892', 'type': 'BACKGROUND', 'citation': 'Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.'}, {'pmid': '21519308', 'type': 'BACKGROUND', 'citation': 'Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.'}, {'pmid': '20881527', 'type': 'BACKGROUND', 'citation': 'Thornton PC, Grant SA, Breslin DS. Adjuncts to local anesthetics in peripheral nerve blockade. Int Anesthesiol Clin. 2010 Fall;48(4):59-70. doi: 10.1097/AIA.0b013e3181f89af1. No abstract available.'}, {'pmid': '16428570', 'type': 'BACKGROUND', 'citation': 'Bigat Z, Boztug N, Hadimioglu N, Cete N, Coskunfirat N, Ertok E. Does dexamethasone improve the quality of intravenous regional anesthesia and analgesia? A randomized, controlled clinical study. Anesth Analg. 2006 Feb;102(2):605-9. doi: 10.1213/01.ane.0000194944.54073.dd.'}, {'pmid': '12538215', 'type': 'BACKGROUND', 'citation': 'Kopacz DJ, Lacouture PG, Wu D, Nandy P, Swanton R, Landau C. The dose response and effects of dexamethasone on bupivacaine microcapsules for intercostal blockade (T9 to T11) in healthy volunteers. Anesth Analg. 2003 Feb;96(2):576-82, table of contents. doi: 10.1097/00000539-200302000-00050.'}, {'pmid': '12818954', 'type': 'BACKGROUND', 'citation': 'Kopacz DJ, Bernards CM, Allen HW, Landau C, Nandy P, Wu D, Lacouture PG. A model to evaluate the pharmacokinetic and pharmacodynamic variables of extended-release products using in vivo tissue microdialysis in humans: bupivacaine-loaded microcapsules. Anesth Analg. 2003 Jul;97(1):124-31, table of contents. doi: 10.1213/01.ane.0000067531.49000.c1.'}, {'pmid': '9778015', 'type': 'BACKGROUND', 'citation': 'Drager C, Benziger D, Gao F, Berde CB. Prolonged intercostal nerve blockade in sheep using controlled-release of bupivacaine and dexamethasone from polymer microspheres. Anesthesiology. 1998 Oct;89(4):969-79. doi: 10.1097/00000542-199810000-00022.'}, {'pmid': '16368840', 'type': 'BACKGROUND', 'citation': 'Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.'}, {'pmid': '19668281', 'type': 'BACKGROUND', 'citation': 'Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, Benyamin RM, Falco FJ, Helm S, Hayek SM, Smith HS; ASIPP. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E123-98.'}, {'pmid': '12170044', 'type': 'BACKGROUND', 'citation': 'Holte K, Werner MU, Lacouture PG, Kehlet H. Dexamethasone prolongs local analgesia after subcutaneous infiltration of bupivacaine microcapsules in human volunteers. Anesthesiology. 2002 Jun;96(6):1331-5. doi: 10.1097/00000542-200206000-00011.'}, {'pmid': '20814282', 'type': 'BACKGROUND', 'citation': "Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9."}, {'pmid': '20009936', 'type': 'BACKGROUND', 'citation': 'Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.'}, {'type': 'BACKGROUND', 'citation': "Raj's Practical Management of Pain, 4th ed. Benzon HT, Rathmel JP, Wu CL, Turk DC, Argoff CE, eds. Philadelphia: Mosby/Elsevier, 2008."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the Finger Blood Glucose (sugar) when dexamethasone is added to a local anesthetic for a shoulder nerve block procedure. The investigators hypothesize that there is no increase in plasma glucose when 8 mg of dexamethasone is used as an adjuvant with local anesthetic to interscalene regional anesthesia. By performing finger stick blood glucose measures pre/peri and post operatively the investigators will be able to determine if any such increase exists.', 'detailedDescription': 'Patients receiving regional anesthesia for orthopedic surgeries are provided with significant pain relief in the post-operative period. Dexamethasone as an adjuvant to local anesthetic has been shown to provide increased duration of block without adverse effects. Use of steroids as adjuvants are restricted to non-diabetics due to concern for increased plasma glucose from systemic absorption. The investigators hypothesize that there will be no difference(increase) from patient baseline(preoperative plasma glucose) in plasma glucose levels up to 4 hours post nerve block in patients who receive 8 mg of dexamethasone used as an adjuvant with local anesthetic to interscalene regional anesthesia. Research has demonstrated the safety and efficacy of dexamethasone as an adjuvant to local anesthetic in peripheral nerve block. Currently there are no studies which document any plasma glucose effects(or lack of effects) from dexamethasone used as an adjuvant to regional anesthesia. Currently dexamethasone is used clinically off label by anesthesiologists as an adjuvant in association with local anesthetic for nerve block anesthesia. Once studies are completed, the investigators hope to allow diabetics to also receive the prolongation of pain relief associated with the use of steroid as an adjuvant. In addition, the increased educational and pharmacological data gleamed from the data can potentially be utilized for future studies with dexamethasone utilized perineurally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 or ASA 2 male or female non pregnant patients undergoing elective shoulder arthroscopy for surgical repair.\n\nExclusion Criteria:\n\n* severe lung disease\n* contralateral diaphragmatic paralysis\n* coagulopathy\n* pregnancy\n* pre-existing neuropathy involving the surgical limb\n* systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery\n* chronic opioid use (30 mg oral oxycodone equivalent per day)\n* diabetes I or II\n* diagnosis of "pre-diabetes"\n* currently prescribed any of the oral glucose medications :sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, or DPP-4 inhibitors.'}, 'identificationModule': {'nctId': 'NCT01538459', 'briefTitle': 'Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block', 'organization': {'class': 'OTHER', 'fullName': 'Lifespan'}, 'officialTitle': 'Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block', 'orgStudyIdInfo': {'id': 'NHCNE.2012.0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': '50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone and Bupivacaine', 'description': '50 randomized participants in group will 8 mg(2cc of 4mg/cc solution) Dexamethasone added to 20 cc 0.25% bupivacaine in one syringe resulting in 364 µgm/cc for injection. Injected perineurally for interscalene nerve block pre-operatively.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': '8mg (2cc 4mg/cc Solution) mixed with 20 cc 0.25% bupivacaine in one syringe resulting in 364 µgm/cc for injection in perineural space. One time dose during nerve block preoperatively.', 'armGroupLabels': ['Dexamethasone and Bupivacaine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Control Group receives 20 cc 0.25% bupivacaine without any adjuvants', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02840', 'city': 'Newport', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Newport Hospital', 'geoPoint': {'lat': 41.4901, 'lon': -71.31283}}], 'overallOfficials': [{'name': 'Geoffrey W Wilson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Navy'}, {'name': 'Raul Masing, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lifespan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifespan', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Naval Medical Center, Portsmouth', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist, Principal Investigator', 'investigatorFullName': 'Geoffrey Wilson, M.D.', 'investigatorAffiliation': 'United States Naval Medical Center, Portsmouth'}}}}