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

NCT07249827 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-11084
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Analgesia; Pain, Acute; Nerve Block; Upper Extremity Surgery

Keywords

Analgesia; Acute pain; Brachial plexus; Brachial plexus block; Postoperative pain; Nerve block

Outcome Measures

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

  24-48 hours after block

Secondary Outcomes (14)

• Sensory block duration

  24-48 hours after block

• Analgesic block duration

  24-48 hours after block

• Block performance time

  1 hour before surgery

• Intensity of pain during block procedure

  1 hour before surgery

• Block onset time

  1 hour before surgery

Study Arms (3)

0.67 mcg/kg

EXPERIMENTAL

Addition of dexmedetomidine 0.67 mcg/kg to local anesthetics in infraclavicular brachial plexus block

Drug: dexmedetomidine (perineural) 0.67 mcg/kg

1 mcg/kg

EXPERIMENTAL

Addition of dexmedetomidine 1 mcg/kg to local anesthetics in infraclavicular brachial plexus block

Drug: dexmedetomidine (perineural) 1 mcg/kg

1.33 mcg/kg

EXPERIMENTAL

Addition of dexmedetomidine 1.33 mcg/kg to local anesthetics in infraclavicular brachial plexus block

Drug: dexmedetomidine (perineural) 1.33 mcg/kg

Interventions

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.

1.33 mcg/kg

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.

0.67 mcg/kg

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.

1 mcg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (23)

• 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.

  PMID: 37550610 BACKGROUND

• 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.

  PMID: 29668608 BACKGROUND

• 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.

  PMID: 21270721 BACKGROUND

• 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.

  PMID: 32398441 BACKGROUND

• 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.

  PMID: 30679332 BACKGROUND

• 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.

  PMID: 27015544 BACKGROUND

• 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.

  PMID: 25695189 BACKGROUND

• 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.

  PMID: 23161360 BACKGROUND

• 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.

  PMID: 22826530 BACKGROUND

• 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.

  PMID: 29505435 BACKGROUND

• 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.

  PMID: 27792047 BACKGROUND

• 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.

  PMID: 27650364 BACKGROUND

• 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.

  PMID: 21666435 BACKGROUND

• 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.

  PMID: 20814283 BACKGROUND

• 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.

  PMID: 19858875 BACKGROUND

• Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.

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• Tezuka M, Kitajima T, Yamaguchi S, Kimura Y, Hamaguchi S. Addition of dexmedetomidine prolongs duration of vasodilation induced by sympathetic block with mepivacaine in dogs. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):323-7. doi: 10.1016/j.rapm.2004.03.004.

  PMID: 15305251 BACKGROUND

• Poree LR, Guo TZ, Kingery WS, Maze M. The analgesic potency of dexmedetomidine is enhanced after nerve injury: a possible role for peripheral alpha2-adrenoceptors. Anesth Analg. 1998 Oct;87(4):941-8. doi: 10.1097/00000539-199810000-00037.

  PMID: 9768799 BACKGROUND

• Abdulatif M, Fawzy M, Nassar H, Hasanin A, Ollaek M, Mohamed H. The effects of perineural dexmedetomidine on the pharmacodynamic profile of femoral nerve block: a dose-finding randomised, controlled, double-blind study. Anaesthesia. 2016 Oct;71(10):1177-85. doi: 10.1111/anae.13603.

  PMID: 27611039 BACKGROUND

• Ghazaly HF, Aly AAA, Zaher ZZ, Hassan MM, Mahmoud AA. Comparison of the efficacy of two doses of dexmedetomidine as an adjunct to levobupivacaine in infraclavicular brachial plexus block: prospective double-blinded randomized controlled trial. BMC Anesthesiol. 2022 Nov 5;22(1):338. doi: 10.1186/s12871-022-01858-4.

  PMID: 36335297 BACKGROUND

• Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.

  PMID: 30640652 BACKGROUND

• Aliste J, Layera S, Bravo D, Aguilera G, Erpel H, Garcia A, Lizama M, Finlayson RJ, Tran D. Randomized comparison between perineural dexamethasone and combined perineural dexamethasone-dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2022 Jun 21:rapm-2022-103760. doi: 10.1136/rapm-2022-103760. Online ahead of print.

  PMID: 35728840 BACKGROUND

• Aliste J, Layera S, Bravo D, Fernandez D, Jara A, Garcia A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100680. doi: 10.1136/rapm-2019-100680. Online ahead of print.

  PMID: 31300595 BACKGROUND

MeSH Terms

Conditions

Agnosia; Acute Pain; Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Julián Aliste, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julián Aliste, MD

CONTACT

514-934-1934; julian.aliste@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: blinded-randomized controlled trial

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)