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Study of Use of Dexmedetomidine for Regional Anesthesia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01969903
First received: October 14, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to find out the proper amount of a drug called dexmedetomidine added to the local anesthetic drug called lidocaine to prolong the time and effect of pain relief provided for surgery.

Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA) and indicated for sedation (calming effect). It has both pain relieving and calming effects when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to lidocaine decreased blood pressure and heart rate. The investigators plan to study the effect of lower amounts of dexmedetomidine to achieve the same level and duration of pain relief without reduction of blood pressure and heart rate.


Condition Intervention Phase
Patients Scheduled for Upper Extremity Surgeries (Vascular Occlusion Syndrome, Acute Compartment Syndrome, Capral Tunnell Syndrome Etc.)
Will Participate in the Study.
Focus of the Study is to Determine:
the Optimal Dose of Dexmedetomidine Added to Lidocaine
for Infra- and Supra-clavicular Brachial Plexus Block.
Drug: Precedex injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine Added to Lidocaine for Infra- and Supraclavicular Brachial Plexus Block

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Pain scores on Visual Analog Scale will be measured [ Time Frame: Heart rate will be monitored continuously and the blood pressure - every 5 min during the entire surgical procedure, because dexmedetomidine can cause bradycardia and hypotension. Participants will be followed for the duration of hospital stay. ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No dexmedetomidine injected
Control group in which will be used only lidocaine for brachial plexus block
Drug: Precedex injection
Other Name: precedex
Experimental: 0.3 microgs/kg of dexmedetomidine
Experimenta group, in which 0.3 microgs/kg dexmedetomidin will be added to lidocaine for brachial plexus block
Drug: Precedex injection
Other Name: precedex
Experimental: 0.6 microgs/kg of dexmedeomidine
Experimental group, in which 0.6 microgs/kg dexmedetomidin will be added to lidocaine for brachial plexus block
Drug: Precedex injection
Other Name: precedex

Detailed Description:

Administered intravenously dexmedetomidine exhibits a wide range of effects that include sedation, analgesia and sympathetic activities, which translate into hemodynamic stability and anesthetic dose reduction. Recent several experimental works had demonstrated prolongation of peripheral nerve block with addition of dexmedetomidine. One human study substantiated this fact when 100µg of dexmedetomidine was added to levobupivacaine during an axillary approach brachial plexus block. This study also showed that dexmedetomidine used in this fashion resulted in lower systolic and diastolic pressures and heart rates as compared to those patients who did not receive the drug. Bradycardia requiring treatment with atropine occurred in 7 out of 30 patients (23%).

The aim of this randomized prospective study is to determine the optimal dose of dexmedetomidine added to lidocaine for infra- and supra-clavicular brachial plexus block. The investigators plan to establish a dose response relationship using 0.3µg/kg and 0.6µg/kg of dexmedetomidine added to lidocaine, epinephrine and bicarbonate mixture during infra- and supraclavicular brachial plexus block for upper extremity surgery. The doses to be used in this study are substantially lower than 100 µg dose used with levobupivacaine previously.

The investigators hypothesis is that dexmedetomidine added to lidocaine at these doses will shorten the onset and prolong the duration of brachial plexus block without significant hypotension or bradycardia.

Significant hypotension will be defined as 25% reduction of mean arterial blood pressure from the baseline or reduction of mean arterial blood pressure below 60 mm Hg.

Significant bradycardia will be defined as 25% reduction of the heart rate from the baseline or a heart rate less than 50 bpm.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients (within the age range described above) of all racial and ethnic origin, accepted to Bellevue Hospital for upper extremity surgeries, will be included in the study. Research will include only subjects who will have regional anesthesia as standard of care.

Exclusion Criteria:

The patients with history of hypersensitivity to local anesthetics, hematological diseases, bleeding or coagulation abnormalities, mental impairment, neurologic diseases, unstable cardiac, hepatic, end-stage renal, pulmonary and coagulation abnormality, history of drug abuse will not be included in the study. Vulnerable subjects also will be excluded from the study.

Patients with baseline heart rate lower than 65 bpm, blood pressure lower than 100/60, and with known allergy to precedex will be excluded from the study. Vulnerable subjects (i.e. children, pregnant women, prisoners, cognitively impaired) will be excluded from the study.

  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01969903     History of Changes
Other Study ID Numbers: S13-00716
Study First Received: October 14, 2013
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
brachial plexus block
lidocaine
dexnedetomidine
bradycardia
hypotension

Additional relevant MeSH terms:
Compartment Syndromes
Syndrome
Cardiovascular Diseases
Disease
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Vascular Diseases
Dexmedetomidine
Lidocaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on November 24, 2014