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Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610893
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Julian Aliste, University of Chile

Tracking Information
First Submitted Date  ICMJE July 4, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE August 16, 2018
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
Motor block duration [ Time Frame: 24 hours after block ]
Elapsed time since the end of LA injection until return of hand and fingers movement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Sensory block duration [ Time Frame: 24 hours after block ]
    Elapsed time since the end of LA injection until return of hand and fingers sensation
  • Analgesic block duration [ Time Frame: 24 hours after block ]
    Elapsed time since the end of LA injection until first sensation of pain in surgical area
  • Block performance time [ Time Frame: 1 hour before surgery ]
    Elapsed time from skin desinfection until the end of LA injection
  • Intensity of pain during block procedure [ Time Frame: 1 hour before surgery ]
    Evaluated with a numeric rating score from 0 to 10
  • Block onset time [ Time Frame: 1 hour before surgery ]
    Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points
  • Sensory and motor block score [ Time Frame: 30 minutes post injection ]
    Sensorimotor block assessed every 5 minutes until 30 minutes using a 16-point composite score evaluating sensory and motor block of musculocutaneus, medium, radial and ulnar nerves. Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch. Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Succesfull blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
  • Incidence of complete block [ Time Frame: 30 minutes post injection ]
    Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes post injection
  • Perioperative glycemic levels [ Time Frame: Perioperative period ]
    Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
  • Perioperative median artery pressure (MAP) [ Time Frame: 2 hours after surgery ]
    Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
  • Perioperative heart rate (HR) [ Time Frame: 2 hours after surgery ]
    Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
  • Postoperative persistent sedation [ Time Frame: 2 hours after surgery ]
    Persistent sedation after surgery using Ramsay sedation scale. 1= anxious agitated or restless; 2= co-operative, oriented and tranquil; 3= responds to command only; 4= brisk response to light pain or loud auditory stimulus; 5= sluggish response to light pain or loud auditory stimulus; 6= no response.
  • Respiratory depression [ Time Frame: 2 hours after surgery ]
    Low respiratory rate (lower than 8 breaths per minute) or persistent oxygen requirement (pulse oximetry lower than 90% without supplementary oxygen)
  • Incidence of block side effects [ Time Frame: 2 hours after surgery ]
    Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness
  • Persistent neurologic deficit [ Time Frame: 7 days post surgery ]
    Presence of persistent sensory or motor postoperative deficit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
Official Title  ICMJE A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks
Brief Summary

When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve blocks. These drugs have important differences in terms of cost and safety profiles. This randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided infraclavicular brachial plexus blocks (ICBs).

Since analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. The protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. The equivalency margin is set at 3 hrs.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Postoperative
  • Pain, Acute
  • Upper Extremity Injury
Intervention  ICMJE
  • Drug: Dexamethasone
    Dexamethasone as perineural local anesthetic adjuvant
  • Drug: Dexmedetomidine
    Dexmedetomidine as perineural local anesthetic adjuvant
Study Arms  ICMJE
  • Active Comparator: Perineural dexamethasone
    addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
    Intervention: Drug: Dexamethasone
  • Active Comparator: Perineural dexmedetomidine
    addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
    Intervention: Drug: Dexmedetomidine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age between 18 and 75 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 35

Exclusion Criteria:

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • allergy to local anesthetics (LAs)
  • pregnancy
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03610893
Other Study ID Numbers  ICMJE 953/18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julian Aliste, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date April 2019

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