- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538459
Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
May 17, 2013 updated by: Geoffrey Wilson, M.D., Lifespan
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Newport, Rhode Island, United States, 02840
- Newport Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine
50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
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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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours
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Time until first narcotic usage post operatively
Time Frame: 14 days
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Patients will be called for follow-up days 1, 2 and 14 and provided with a pain diary to document first narcotic usage.
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14 days
|
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.
|
14 Days
|
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.
|
14 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Geoffrey W Wilson, M.D., United States Navy
- Principal Investigator: Raul Masing, M.D., Lifespan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Raj's Practical Management of Pain, 4th ed. Benzon HT, Rathmel JP, Wu CL, Turk DC, Argoff CE, eds. Philadelphia: Mosby/Elsevier, 2008.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
February 23, 2012
First Posted (Estimate)
February 24, 2012
Study Record Updates
Last Update Posted (Estimate)
May 20, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
- Humans
- Drug Therapy, Combination
- Prospective Studies
- Injections
- Adult
- Dexamethasone
- Female
- Male
- Bupivacaine
- Blood Glucose
- Glucocorticoids
- Regional Anesthesia
- Physiological Effects of Drugs
- Anesthetics
- Sensory System Agents
- Anesthetics, Local
- Therapeutic Uses
- Anti-Inflammatory Agents
- Time Factors
- Anesthesiology
- Adjuvants, Anesthesia
- Pain, Postoperative/prevention & control
- Brachial Plexus/ultrasonography
- Nerve Block/methods
- Analgesia/methods
- Interscalene Nerve Block
- Pain Blockade
- Arthroscopic Surgery
- Arthroscopic rotator cuff repair
- Brachial Plexus/drug effects
- Brachial Plexus/surgery
- Bupivacaine/administration & dosage
- Dexamethasone/administration & dosage
- Pain, Postoperative/etiology
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Arthralgia
- Disease
- Tendinopathy
- Shoulder Pain
- Shoulder Injuries
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Dexamethasone
- Bupivacaine
Other Study ID Numbers
- NHCNE.2012.0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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