Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
|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Recruitment Status : Withdrawn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.
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|