Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain; Injury of Shoulder Region; Disorder of Shoulder; Disorder of Rotator Cuff; Disorder of Tendon of Biceps	Drug: Dexamethasone; Drug: Bupivacaine	Phase 3

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
Study Start Date :	November 2012
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Bupivacaine; 50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.	Drug: Bupivacaine; Control Group receives 20 cc 0.25% bupivacaine without any adjuvants
Experimental: Dexamethasone and Bupivacaine; 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.	Drug: Dexamethasone; 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.; Other Name: Decadron

Outcome Measures

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Primary Outcome Measures :

1. Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block. [ Time Frame: 4 hours ]
   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.

Secondary Outcome Measures :

1. Pain post-operative(immediately)- both at rest and with movement(VAS Scale) [ Time Frame: 4 hours ]
   Investigators will document patient pain in post-anesthesia care unit (both at rest and with movement)utilizing the VAS scale.
2. Time until first narcotic usage post operatively [ Time Frame: 14 days ]
   Patients will be called for follow-up days 1, 2 and 14 and provided with a pain diary to document first narcotic usage.
3. Block Quality and Duration(time until first motor return) [ Time Frame: 14 Days ]
   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.
4. Block Quality and Duration(time until first sensory return) [ Time Frame: 14 Days ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

United States, Rhode Island
Newport Hospital
Newport, Rhode Island, United States, 02840

Sponsors and Collaborators

Lifespan

United States Naval Medical Center, Portsmouth

Investigators

Principal Investigator:	Geoffrey W Wilson, M.D.	United States Navy
Principal Investigator:	Raul Masing, M.D.	Lifespan

More Information

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Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Raj's Practical Management of Pain, 4th ed. Benzon HT, Rathmel JP, Wu CL, Turk DC, Argoff CE, eds. Philadelphia: Mosby/Elsevier, 2008.

Responsible Party:	Geoffrey Wilson, M.D., Staff Anesthesiologist, Principal Investigator, United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:	NCT01538459 History of Changes
Other Study ID Numbers:	NHCNE.2012.0001
First Posted:	February 24, 2012
Last Update Posted:	May 20, 2013
Last Verified:	May 2013

Keywords provided by Geoffrey Wilson, M.D., United States Naval Medical Center, Portsmouth:

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

Additional relevant MeSH terms:

Disease; Shoulder Pain; Shoulder Injuries; Tendinopathy; Pathologic Processes; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Wounds and Injuries; Muscular Diseases; Tendon Injuries	Dexamethasone acetate; Dexamethasone; Bupivacaine; BB 1101; Anesthetics; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal