Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
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ClinicalTrials.gov Identifier: NCT01538459 |
Recruitment Status
:
Withdrawn
First Posted
: February 24, 2012
Last Update Posted
: May 20, 2013
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Condition or disease | Intervention/treatment | Phase |
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Shoulder Pain Injury of Shoulder Region Disorder of Shoulder Disorder of Rotator Cuff Disorder of Tendon of Biceps | Drug: Dexamethasone Drug: Bupivacaine | Phase 3 |
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 |

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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Drug: Bupivacaine
Control Group receives 20 cc 0.25% bupivacaine without any adjuvants
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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.
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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
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- 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.
- 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.
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538459
United States, Rhode Island | |
Newport Hospital | |
Newport, Rhode Island, United States, 02840 |
Principal Investigator: | Geoffrey W Wilson, M.D. | United States Navy | |
Principal Investigator: | Raul Masing, M.D. | Lifespan |
Publications:
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 Key Record Dates |
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 |