Shoulder Pain Clinical Trial
Official title:
Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - ASA 1 or ASA 2 male or female non pregnant patients undergoing elective shoulder arthroscopy for surgical repair. Exclusion Criteria: - severe lung disease - contralateral diaphragmatic paralysis - coagulopathy - pregnancy - pre-existing neuropathy involving the surgical limb - systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery - chronic opioid use (30 mg oral oxycodone equivalent per day) - diabetes I or II - diagnosis of "pre-diabetes" - currently prescribed any of the oral glucose medications :sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, or DPP-4 inhibitors. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Newport Hospital | Newport | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Lifespan | United States Naval Medical Center, Portsmouth |
United States,
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. — View 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. — View Citation
Dräger 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
Raj's Practical Management of Pain, 4th ed. Benzon HT, Rathmel JP, Wu CL, Turk DC, Argoff CE, eds. Philadelphia: Mosby/Elsevier, 2008.
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. Review. — View 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. — View 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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block. | 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. | 4 hours | No |
Secondary | Pain post-operative(immediately)- both at rest and with movement(VAS Scale) | Investigators will document patient pain in post-anesthesia care unit (both at rest and with movement)utilizing the VAS scale. | 4 hours | No |
Secondary | Time until first narcotic usage post operatively | Patients will be called for follow-up days 1, 2 and 14 and provided with a pain diary to document first narcotic usage. | 14 days | No |
Secondary | Block Quality and Duration(time until first motor return) | 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. | 14 Days | No |
Secondary | Block Quality and Duration(time until first sensory return) | 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. | 14 Days | No |
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