Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

NCT01538459 | Withdrawn Phase 3

• 1 other identifier: NHCNE.2012.0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Injury of Shoulder Region; Disorder of Shoulder; Disorder of Rotator Cuff; Disorder of Tendon of Biceps

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Pain post-operative(immediately)- both at rest and with movement(VAS Scale)

  4 hours

• Time until first narcotic usage post operatively

  14 days

• Block Quality and Duration(time until first motor return)

  14 Days

• Block Quality and Duration(time until first sensory return)

  14 Days

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.

Drug: Bupivacaine

Dexamethasone and Bupivacaine

EXPERIMENTAL

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

Interventions

Dexamethasone DRUG

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.

Also known as: Decadron

Dexamethasone and Bupivacaine

Bupivacaine DRUG

Control Group receives 20 cc 0.25% bupivacaine without any adjuvants

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 or ASA 2 male or female non pregnant patients undergoing elective shoulder arthroscopy for surgical repair.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifespan: lead
• United States Naval Medical Center, Portsmouth: collaborator

Study Sites (1)

Newport Hospital

Newport, Rhode Island, 02840, United States

Location

Related Publications (13)

• 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: 21676892 BACKGROUND

• 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: 21519308 BACKGROUND

• 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: 20881527 BACKGROUND

• 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: 16428570 BACKGROUND

• 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: 12538215 BACKGROUND

• 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: 12818954 BACKGROUND

• 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: 9778015 BACKGROUND

• 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: 16368840 BACKGROUND

• 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: 19668281 BACKGROUND

• 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: 12170044 BACKGROUND

• 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: 20814282 BACKGROUND

• 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.

  PMID: 20009936 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Agnosia; Pain

Interventions

Dexamethasone; Calcium Dobesilate; Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Geoffrey W Wilson, M.D.

  United States Navy

  PRINCIPAL INVESTIGATOR

• Raul Masing, M.D.

  Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 24, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

US (1)