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Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

Primary Purpose

Shoulder Pain, Injury of Shoulder Region, Disorder of Shoulder

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Bupivacaine
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Newport Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine

Dexamethasone and Bupivacaine

Arm Description

50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.

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.

Outcomes

Primary Outcome Measures

Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.
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)
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
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)
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)
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.

Full Information

First Posted
February 20, 2012
Last Updated
May 17, 2013
Sponsor
Lifespan
Collaborators
United States Naval Medical Center, Portsmouth
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1. Study Identification

Unique Protocol Identification Number
NCT01538459
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan
Collaborators
United States Naval Medical Center, Portsmouth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
50 randomized participants in group receive 20cc 0.25% bupivacaine injected perineurally for interscalene nerve block.
Arm Title
Dexamethasone and Bupivacaine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Control Group receives 20 cc 0.25% bupivacaine without any adjuvants
Primary Outcome Measure Information:
Title
Increased Blood Sugar after Dexamethasone added to local anesthetic for interscalene nerve block.
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Pain post-operative(immediately)- both at rest and with movement(VAS Scale)
Description
Investigators will document patient pain in post-anesthesia care unit (both at rest and with movement)utilizing the VAS scale.
Time Frame
4 hours
Title
Time until first narcotic usage post operatively
Description
Patients will be called for follow-up days 1, 2 and 14 and provided with a pain diary to document first narcotic usage.
Time Frame
14 days
Title
Block Quality and Duration(time until first motor return)
Description
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.
Time Frame
14 Days
Title
Block Quality and Duration(time until first sensory return)
Description
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.
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey W Wilson, M.D.
Organizational Affiliation
United States Navy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul Masing, M.D.
Organizational Affiliation
Lifespan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newport Hospital
City
Newport
State/Province
Rhode Island
ZIP/Postal Code
02840
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21676892
Citation
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20881527
Citation
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Citation
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Results Reference
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Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

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