A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block
NCT ID: NCT07249827
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
69 participants
INTERVENTIONAL
2025-12-28
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
NCT03610893
Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks
NCT04875039
The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery
NCT02225054
Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block
NCT06527976
Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks
NCT02629835
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.67 mcg/kg
Addition of dexmedetomidine 0.67 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 0.67 mcg/kg
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.
1 mcg/kg
Addition of dexmedetomidine 1 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 1 mcg/kg
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.
1.33 mcg/kg
Addition of dexmedetomidine 1.33 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 1.33 mcg/kg
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dexmedetomidine (perineural) 0.67 mcg/kg
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
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age between 18 and 75 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 18 and 35 kg/m2
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Julián Aliste
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julián Aliste, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McGill University Health Centre
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-11084
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.