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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention 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
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

Resource links provided by NLM:


Further study details as provided by Lifespan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
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)
Arms Assigned Interventions
Active Comparator: Bupivacaine
50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
Drug: Bupivacaine
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.
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538459

Locations
United States, Rhode Island
Newport Hospital
Newport, Rhode Island, United States, 02840
Sponsors and Collaborators
Lifespan
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Geoffrey W Wilson, M.D. United States Navy
Principal Investigator: Raul Masing, M.D. Lifespan
  More Information

Publications:

Responsible Party: Geoffrey Wilson, M.D., Staff Anesthesiologist, Principal Investigator, United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier: NCT01538459     History of Changes
Other Study ID Numbers: NHCNE.2012.0001
Study First Received: February 20, 2012
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Lifespan:
Brachial Plexus/drug effects
Brachial Plexus/surgery
Brachial Plexus/ultrasonography
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
Bupivacaine/administration & dosage
Dexamethasone/administration & dosage
Drug Therapy, Combination
Female
Humans
Male
Nerve Block/methods

Additional relevant MeSH terms:
Wounds and Injuries
Tendon Injuries
Shoulder Pain
Tendinopathy
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Muscular Diseases
Adjuvants, Anesthesia
Dexamethasone acetate
Anti-Inflammatory Agents
Dexamethasone
Bupivacaine
Sensory System Agents
Dexamethasone 21-phosphate
BB 1101
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on July 20, 2014