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Completed

NCT Number: NCT03610893

Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

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.

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Key information

Conditions

Pain, Postoperative Acute Pain Arm Injuries Neurologic Manifestations Pain Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Upper Extremity Injury Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone as perineural local anesthetic adjuvant

Dexmedetomidine

Drug

Dexmedetomidine as perineural local anesthetic adjuvant

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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