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Recruitment Status : Withdrawn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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Bupivacaine
50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
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 Name: Decadron
- 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.
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, Rhode Island, United States, 02840|
|Principal Investigator:||Geoffrey W Wilson, M.D.||United States Navy|
|Principal Investigator:||Raul Masing, M.D.||Lifespan|