A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

This study will compare three different doses of perineural dexmedetomidine 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). Our research hypothesis is that 1.33 mcg/kg will provide a 15%-longer duration than 1mcg/kg, which in turn will provide a 15%-longer duration than 0.67 mcg/kg. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, respectively, we will select motor block duration as the main outcome to better target the action of dexmedetomidine on the brachial plexus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing upper limb surgery at or below the elbow

age between 18 and 75 years

American Society of Anesthesiologists classification 1-3

body mass index between 18 and 35 kg/m2

Disqualifiers

adults who are unable to give their own consent

allergy or contraindication to dexmedetomidine

exposure to dexmedetomidine during the previous 48 hrs

pre-existing neuropathy (assessed by history and physical examination)

Trial design

Design model

Parallel

Treatments tested in this trial

  • dexmedetomidine (perineural) 0.67 mcg/kg

    Drug

    Perineural dexmedetomidine 0.67 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.

  • dexmedetomidine (perineural) 1 mcg/kg

    Drug

    Perineural dexmedetomidine 1 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.

  • dexmedetomidine (perineural) 1.33 mcg/kg

    Drug

    Perineural dexmedetomidine 1.33 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.

Treatment groups

69 Participants
are divided into 3 treatment groups
Group A: 0.67 mcg/kgExperimental treatment 1 intervention
Group B: 1 mcg/kgExperimental treatment 1 intervention
Group C: 1.33 mcg/kgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Motor block duration

The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement

Time frame
24-48 hours after block

Secondary outcomes

1

Sensory block duration

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

Time frame
24-48 hours after block
2

Analgesic block duration

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

Time frame
24-48 hours after block
3

Block performance time

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)

Time frame
1 hour before surgery
4

Intensity of pain during block procedure

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.

Time frame
1 hour before surgery

Other outcomes

Sponsors and contacts

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