NCT01538459

Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lifespan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Shoulder Pain
• Injury of Shoulder Region
• Disorder of Shoulder
• Disorder of Rotator Cuff
• Disorder of Tendon of Biceps

Interventions

Type	Name	Description
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.
DRUG	Bupivacaine	Control Group receives 20 cc 0.25% bupivacaine without any adjuvants

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-24
• Last updated: 2013-05-20

Locations

1 site across 1 country: United States