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Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

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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

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Acute Upper Extremity Injury Drug: Dexamethasone Drug: Dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Perineural dexamethasone
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Drug: Dexamethasone
Dexamethasone as perineural local anesthetic adjuvant

Active Comparator: Perineural dexmedetomidine
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Drug: Dexmedetomidine
Dexmedetomidine as perineural local anesthetic adjuvant




Primary Outcome Measures :
  1. Motor block duration [ Time Frame: 24 hours after block ]
    Elapsed time since the end of LA injection until return of hand and fingers movement


Secondary Outcome Measures :
  1. Sensory block duration [ Time Frame: 24 hours after block ]
    Elapsed time since the end of LA injection until return of hand and fingers sensation

  2. 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

  3. Block performance time [ Time Frame: 1 hour before surgery ]
    Elapsed time from skin desinfection until the end of LA injection

  4. Intensity of pain during block procedure [ Time Frame: 1 hour before surgery ]
    Evaluated with a numeric rating score from 0 to 10

  5. 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

  6. 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.


  7. 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

  8. Perioperative glycemic levels [ Time Frame: Perioperative period ]
    Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery

  9. 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

  10. Perioperative heart rate (HR) [ Time Frame: 2 hours after surgery ]
    Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period

  11. 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.


  12. 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)

  13. 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

  14. Persistent neurologic deficit [ Time Frame: 7 days post surgery ]
    Presence of persistent sensory or motor postoperative deficit



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610893


Locations
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Chile
Hospital Clínico Universidad de Chile
Santiago, Metropolitana, Chile, 8380456
Sponsors and Collaborators
University of Chile

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian Aliste, Clinical Instructor, University of Chile
ClinicalTrials.gov Identifier: NCT03610893     History of Changes
Other Study ID Numbers: 953/18
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Julian Aliste, University of Chile:
nerve block adjuvants
dexamethasone
dexmedetomidine
nerve block duration
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Arm Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Anesthetics
Anesthetics, Local
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants