Clinical trial NCT01538459: Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
Official title: Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Shoulder Pain
Injury of Shoulder Region
Disorder of Shoulder
Disorder of Rotator Cuff
Disorder of Tendon of Biceps
Keywords: 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
Pain, Postoperative/etiology
Pain, Postoperative/prevention & control
Prospective Studies
Time Factors
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, Portsmouth
First posted: 2012-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.
timeFrame: 4 hours
Secondary outcomes:
measure: Pain post-operative(immediately)- both at rest and with movement(VAS Scale)
timeFrame: 4 hours
measure: Time until first narcotic usage post operatively
timeFrame: 14 days
measure: Block Quality and Duration(time until first motor return)
timeFrame: 14 Days
measure: Block Quality and Duration(time until first sensory return)
timeFrame: 14 Days
Other outcomes:
Locations:
city: Newport
country: United States
facility: Newport Hospital
state: Rhode Island
Study officials:
affiliation: United States Navy
name: Geoffrey W Wilson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lifespan
name: Raul Masing, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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