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Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
Geoffrey Wilson, M.D., United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01538459
First received: February 20, 2012
Last updated: May 17, 2013
Last verified: May 2013

February 20, 2012
May 17, 2013
November 2012
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01538459 on ClinicalTrials.gov Archive Site
  • 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.
Prolongation of Nerve Block Efficacy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
We will document via a pain diary, pt's response to nerve block, time wore off, medications required for pain relief and symptoms experienced when block was wearing off. 14 day point is last of phone calls to pt to document experiences.
Not Provided
Not Provided
 
Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Shoulder Pain
  • Injury of Shoulder Region
  • Disorder of Shoulder
  • Disorder of Rotator Cuff
  • Disorder of Tendon of Biceps
  • 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.
    Other Name: Decadron
  • Drug: Bupivacaine
    Control Group receives 20 cc 0.25% bupivacaine without any adjuvants
  • Active Comparator: Bupivacaine
    50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
    Intervention: Drug: Bupivacaine
  • 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.
    Intervention: Drug: Dexamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01538459
NHCNE.2012.0001
No
Geoffrey Wilson, M.D., United States Naval Medical Center, Portsmouth
Lifespan
United States Naval Medical Center, Portsmouth
Principal Investigator: Geoffrey W Wilson, M.D. United States Navy
Principal Investigator: Raul Masing, M.D. Lifespan
Lifespan
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP