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Dexametasone Versus Dexametasone Plus Dexmedetomidine in 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: NCT04875039
Recruitment Status : Completed
First Posted : May 6, 2021
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Julian Aliste, University of Chile

Brief Summary:
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration. Furthermore, since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves, respectively, motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus.

Condition or disease Intervention/treatment Phase
Analgesia Pain, Acute Upper Extremity Injury Drug: Dexamethasone Drug: Dexmedetomidine-Dexamethasone Phase 4

Detailed Description:

With the approval of Ethics Committee of the Hospital Clínico Universidad de Chile, a total of 50 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care in the preoperative clinic or during routine preoperative visits.

All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room.

After skin disinfection and draping, the ICB will be performed with a previously described technique. In both groups, a proven 90% effective volume of 35 mL of local anesthetic solution will be injected. As LA solution, it will be used a mixture of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL. The injectate will be slowly injected through the block needle.

Patients will be randomized to receive the study drug, either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine, mixed with the above-mentioned LA solution.

A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient and investigator assessing the block will be blinded to group allocation.

The primary outcome will be the duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers) for patients with successful ICBs. Patients will be provided with a data sheet and asked to record the time at which motor function returns. An investigator blinded to group allocation will collect this data sheet in person (inpatients) or by phone (outpatients) on postoperative day 1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: blinded-randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A research assistant (licensed anesthesiologist) will prepare the local anesthetic solutions and will add the study drug following the randomization order. The operator, patient and investigator assessing the block will be blinded to group allocation.
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
Actual Study Start Date : August 31, 2021
Actual Primary Completion Date : March 1, 2022
Actual Study Completion Date : March 1, 2022


Arm Intervention/treatment
Active Comparator: Perineural dexamethasone
Addition of dexamethasone 2mg to local anesthetics in infraclavicular brachial plexus block
Drug: Dexamethasone
dexamethasone 2 mg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.

Experimental: Perineural dexamethasone plus dexmedetomidine
Addition of dexamethasone plus dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Drug: Dexmedetomidine-Dexamethasone
A mixture of dexamethasone 2mg with dexmedetomidine 50mcg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.




Primary Outcome Measures :
  1. Motor block duration [ Time Frame: 24-48 hours after block ]
    The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement


Secondary Outcome Measures :
  1. Sensory block duration [ Time Frame: Time Frame: 24-48 hours after nerve block ]
    The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation

  2. Analgesic block duration [ Time Frame: 24-48 hours after nerve block ]
    The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area

  3. Block performance time [ Time Frame: 1 hour before surgery ]
    Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)

  4. Intensity of pain during block procedure [ Time Frame: 1 hour before surgery ]
    Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.

  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. The sensorimotor score is described in outcome 7.

  6. Sensory and motor block score [ Time Frame: 30 minutes after the ending time of local anesthetic injection ]

    The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, 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, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.

    The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.

    Successful 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 after the ending time of local anesthetic injection ]
    Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection

  8. Incidence of surgical anesthesia [ Time Frame: 30-60 minutes after the ending time of local anesthetic injection ]
    Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or local anesthesia infiltration by the surgeon

  9. Incidence of nerve block side effects [ Time Frame: 0 minutes after skin disinfection to 30 minutes after the nerve block ]
    Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome or hoarseness after the block.

  10. Respiratory depression [ Time Frame: 30 minutes after the nerve block to 2 hours after surgery ]

    Presence of low respiratory rates (lower than 8 breaths per minute) or persistent oxygen requirements (pulse oximetry lower than 90% without supplementary oxygen).

    The respiratory rate and pulse oximetry are continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached


  11. Bradycardia [ Time Frame: 30 minutes after the nerve block to 2 hours after surgery ]
    Defined as a heart rate lower than 50 beats per minute. The heart rate is continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached

  12. Hypotension [ Time Frame: 30 minutes after the nerve block to 2 hours after surgery ]
    Mean arterial pressure lower than 60 mmHg. The blood pressure is measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached

  13. Postoperative persistent sedation [ Time Frame: 2 hours after surgery ]

    Persistent sedation after surgery using Ramsay sedation scale. The scale has 6 points from 1 to 6. A higher score represents a more sedated patient.

    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.


  14. Persistent neurologic deficit [ Time Frame: 7 days after surgery ]
    Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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): NCT04875039


Locations
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Chile
Hospital Clínico Universidad de Chile
Santiago, Metropolitan, Chile
Sponsors and Collaborators
University of Chile
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian Aliste, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier: NCT04875039    
Other Study ID Numbers: OAIC 1091/19
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
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:
dexamethasone
dexmedetomidine
nerve block
adjuvants
Additional relevant MeSH terms:
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Acute Pain
Arm Injuries
Pain
Neurologic Manifestations
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
Dexmedetomidine
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
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists