Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
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.
Injury of Shoulder Region
Disorder of Shoulder
Disorder of Rotator Cuff
Disorder of Tendon of Biceps
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block|
- Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|