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AzTrials

AnalgesiaPhase 2NCT07249827

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

A Phase 2 study testing dexmedetomidine (perineural) 0.67 mcg/kg, dexmedetomidine (perineural) 1 mcg/kg and dexmedetomidine (perineural) 1.33 mcg/kg in people with Analgesia and Pain, Acute, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Analgesia, Pain, Acute, Upper Extremity Surgery
What is being tested?
dexmedetomidine (perineural) 0.67 mcg/kg, dexmedetomidine (perineural) 1 mcg/kg and dexmedetomidine (perineural) 1.33 mcg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteCanada
Study dates
28 Dec 2025to 17 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood workup i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. creatinine. eGFR < 90)
Show all 12Show fewer
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. transaminases ≥ 100)
  • allergy to LA
  • pregnancy (as institutional policy, female patients with childbearing potential undergoing non urgent surgery are tested preoperatively for pregnancy with blood tests)
  • breast feeding
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

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.

Read the detailed description

With the approval of Ethics Committee of the McGill University Health Centre, a total of 69 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care one day before surgery

All ICBs will be supervised by 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 each group, 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 plus PN 2 mg dexamethasone. The injectate will be slowly injected through the block needle.

Patients will be randomized to receive the study drug, PN dexmedetomidine 0.67 mcg/kg or PN dexmedetomidine 1 mcg/kg, or PN dexmedetomidine 1.33 mcg/kg 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.

Being tested
dexmedetomidine (perineural) 0.67 mcg/kg, dexmedetomidine (perineural) 1 mcg/kg, dexmedetomidine (perineural) 1.33 mcg/kg
Keywords
Analgesia, Acute pain, Brachial plexus, Brachial plexus block, Postoperative pain, Nerve block
Medical subject headings
Agnosia, Acute Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidine (perineural) 0.67 mcg/kgDrug

    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/kgDrug

    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/kgDrug

    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.

Study groups in NCT07249827
Study groupRoleWhat they receive
0.67 mcg/kgExperimentalAddition of dexmedetomidine 0.67 mcg/kg to local anesthetics in infraclavicular brachial plexus block
Receives: Drug: dexmedetomidine (perineural) 0.67 mcg/kg
1 mcg/kgExperimentalAddition of dexmedetomidine 1 mcg/kg to local anesthetics in infraclavicular brachial plexus block
Receives: Drug: dexmedetomidine (perineural) 1 mcg/kg
1.33 mcg/kgExperimentalAddition of dexmedetomidine 1.33 mcg/kg to local anesthetics in infraclavicular brachial plexus block
Receives: Drug: dexmedetomidine (perineural) 1.33 mcg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24-48 hours after block

Secondary outcomes (14)
  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

    Measured: 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

    Measured: 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)

    Measured: 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.

    Measured: 1 hour before surgery

  5. Block onset time

    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.

    Measured: 1 hour before surgery

  6. Sensory and motor block score

    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.

    Measured: 30 minutes after the ending time of local anesthetic injection

  7. Incidence of complete block

    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

    Measured: 30 minutes after the ending time of local anesthetic injection

  8. Incidence of surgical anesthesia

    Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or local anesthesia infiltration by the surgeon

    Measured: 30-60 minutes after the ending time of local anesthetic injection

  9. Incidence of nerve block side effects

    Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome, hoarseness, or pneumothorax after the block.

    Measured: 0 minutes after skin disinfection to 30 minutes after the nerve block

  10. Respiratory depression

    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

    Measured: 30 minutes after the nerve block to 2 hours after surgery

  11. Bradycardia

    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

    Measured: 30 minutes after the nerve block to 2 hours after surgery

  12. Hypotension

    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

    Measured: 30 minutes after the nerve block to 2 hours after surgery

  13. Postoperative persistent sedation

    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.

    Measured: 2 hours after surgery

  14. Persistent neurologic deficit

    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.

    Measured: 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start28 Dec 2025
  3. Primary completion12 Jun 2026
  4. Study completion17 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
blinded-randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249827
Sponsor's protocol ID
2025-11084
Other IDs
2025
Status last verified
Jul 2026
First submitted
18 Nov 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo Y, Wang J, Jiang P, Wang D, Fan W, Yang X. Effect of erector spinae plane block with different doses of dexmedetomidine as adjuvant for ropivacaine on the postoperative quality of recovery after video-assisted thoracoscopic lobectomy surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Aug 7;23(1):264. doi: 10.1186/s12871-023-02231-9.

    PubMed 37550610
  • Jung HS, Seo KH, Kang JH, Jeong JY, Kim YS, Han NR. Optimal dose of perineural dexmedetomidine for interscalene brachial plexus block to control postoperative pain in patients undergoing arthroscopic shoulder surgery: A prospective, double-blind, randomized controlled study. Medicine (Baltimore). 2018 Apr;97(16):e0440. doi: 10.1097/MD.0000000000010440.

    PubMed 29668608
  • Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.

    PubMed 21270721
  • Ouchi K. Dexmedetomidine 2 ppm Is Appropriate for the Enhancement Effect of Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Preliminary, Randomized Cross-over Study. Clin J Pain. 2020 Aug;36(8):618-625. doi: 10.1097/AJP.0000000000000839.

    PubMed 32398441
  • Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.

    PubMed 30679332
  • Ouchi K, Sugiyama K. Dexmedetomidine Dose Dependently Enhances the Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Randomized Double-Blind Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):348-55. doi: 10.1097/AAP.0000000000000380.

    PubMed 27015544
  • Keplinger M, Marhofer P, Kettner SC, Marhofer D, Kimberger O, Zeitlinger M. A pharmacodynamic evaluation of dexmedetomidine as an additive drug to ropivacaine for peripheral nerve blockade: A randomised, triple-blind, controlled study in volunteers. Eur J Anaesthesiol. 2015 Nov;32(11):790-6. doi: 10.1097/EJA.0000000000000246.

    PubMed 25695189
  • Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

    PubMed 23161360
  • Rancourt MP, Albert NT, Cote M, Letourneau DR, Bernard PM. Posterior tibial nerve sensory blockade duration prolonged by adding dexmedetomidine to ropivacaine. Anesth Analg. 2012 Oct;115(4):958-62. doi: 10.1213/ANE.0b013e318265bab7. Epub 2012 Jul 23.

    PubMed 22826530
  • Kim BS, Choi JH, Baek SH, Lee DH. Effects of Intraneural Injection of Dexmedetomidine in Combination With Ropivacaine in Rat Sciatic Nerve Block. Reg Anesth Pain Med. 2018 May;43(4):378-384. doi: 10.1097/AAP.0000000000000745.

    PubMed 29505435
  • Andersen JH, Grevstad U, Siegel H, Dahl JB, Mathiesen O, Jaeger P. Does Dexmedetomidine Have a Perineural Mechanism of Action When Used as an Adjuvant to Ropivacaine?: A Paired, Blinded, Randomized Trial in Healthy Volunteers. Anesthesiology. 2017 Jan;126(1):66-73. doi: 10.1097/ALN.0000000000001429.

    PubMed 27792047
  • Memari E, Hosseinian MA, Mirkheshti A, Arhami-Dolatabadi A, Mirabotalebi M, Khandaghy M, Daneshbod Y, Alizadeh L, Shirian S. Comparison of histopathological effects of perineural administration of bupivacaine and bupivacaine-dexmedetomidine in rat sciatic nerve. Exp Toxicol Pathol. 2016 Nov;68(10):559-564. doi: 10.1016/j.etp.2016.09.001. Epub 2016 Sep 17.

    PubMed 27650364
  • Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.

    PubMed 21666435
  • Brummett CM, Amodeo FS, Janda AM, Padda AK, Lydic R. Perineural dexmedetomidine provides an increased duration of analgesia to a thermal stimulus when compared with a systemic control in a rat sciatic nerve block. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):427-31. doi: 10.1097/AAP.0b013e3181ef4cf0.

    PubMed 20814283
  • Brummett CM, Padda AK, Amodeo FS, Welch KB, Lydic R. Perineural dexmedetomidine added to ropivacaine causes a dose-dependent increase in the duration of thermal antinociception in sciatic nerve block in rat. Anesthesiology. 2009 Nov;111(5):1111-9. doi: 10.1097/ALN.0b013e3181bbcc26.

    PubMed 19858875

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dexmedetomidine (perineural) 0.67 mcg/kg, dexmedetomidine (perineural) 1 mcg/kg and dexmedetomidine (perineural) 1.33 mcg/kg in people with Analgesia and Pain, Acute, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor block duration (time frame: 24-48 hours after block). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249827, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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