Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks

NCT02629835 | Completed Phase 2

• 1 other identifier: MontrealGH
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief Summary

Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route, intravenous (IV) or perineural (PN), remains controversial. This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV counterpart. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, the investigators will select motor block duration as the main outcome.

Conditions

Brachial Plexus Block Duration

Outcome Measures

Primary Outcomes (1)

• Motor block duration

  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). Patient is contacted at the next day of the surgery and asked about the time when the motor block started to disappear.

  24 hours

Secondary Outcomes (4)

• duration of the sensory block

  24 hours

• Analgesia duration

  24 hours

• Onset time

  30 minutes

• Success rate

  30-60 minutes

Other Outcomes (3)

• Demographic data

  30 minutes

• Side effects

  30-60 minutes

• Persistent deficit

  7 days

Study Arms (2)

Intravenous dexamethasone 8 mg

ACTIVE COMPARATOR

patients receiving intravenous 8 mg of dexamethasone in parallel to ultrasound guided axillary nerve block with a standardized local anesthetic solution

Other: intravenous 8 mg dexamethasone and perineural 0.8 ml of saline solution

Perineural dexamethasone 8 mg

ACTIVE COMPARATOR

patient receiving perineural 8 mg of dexamethasone in a mixture with a standardized local anesthetic solution for ultrasound guided axillary block

Other: intravenous 0,8 ml of saline solution and perineural 8 mg of dexamethasone

Interventions

intravenous 8 mg dexamethasone and perineural 0.8 ml of saline solution OTHER

Intravenous dexamethasone 8 mg

intravenous 0,8 ml of saline solution and perineural 8 mg of dexamethasone OTHER

Perineural dexamethasone 8 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Below Elbow surgery
• Age between 18 and 80 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
• 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 partial 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 axillary region
• Chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• Montreal General Hospital: lead

Study Sites (3)

Montreal General Hospital, McGill University

Montreal, Quebec, H3G 1A4, Canada

Location

Ramathibodi Hospital, Mahidol University,

Bangkok, Bangkok, 50200, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Chiang Mai, 10400, Thailand

Location

Related Publications (16)

• Persec J, Persec Z, Kopljar M, Zupcic M, Sakic L, Zrinjscak IK, Marinic DK. Low-dose dexamethasone with levobupivacaine improves analgesia after supraclavicular brachial plexus blockade. Int Orthop. 2014 Jan;38(1):101-5. doi: 10.1007/s00264-013-2094-z. Epub 2013 Sep 6.

  PMID: 24173676 BACKGROUND

• Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.

  PMID: 20009936 RESULT

• Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.

  PMID: 21681533 RESULT

• Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.

  PMID: 21676892 RESULT

• Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.

  PMID: 24817819 RESULT

• Shrestha BR, Maharjan SK, Tabedar S. Supraclavicular brachial plexus block with and without dexamethasone - a comparative study. Kathmandu Univ Med J (KUMJ). 2003 Jul-Sep;1(3):158-60.

  PMID: 16388222 RESULT

• Yadav RK, Sah BP, Kumar P, Singh SN. Effectiveness of addition of neostigmine or dexamethasone to local anaesthetic in providing perioperative analgesia for brachial plexus block: A prospective, randomized, double blinded, controlled study. Kathmandu Univ Med J (KUMJ). 2008 Jul-Sep;6(23):302-9. doi: 10.3126/kumj.v6i3.1704.

  PMID: 20071811 RESULT

• Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9.

  PMID: 20814282 RESULT

• Biradar PA, Kaimar P, Gopalakrishna K. Effect of dexamethasone added to lidocaine in supraclavicular brachial plexus block: A prospective, randomised, double-blind study. Indian J Anaesth. 2013 Mar;57(2):180-4. doi: 10.4103/0019-5049.111850.

  PMID: 23825819 RESULT

• Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.

  PMID: 25629321 RESULT

• Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.

  PMID: 16368840 RESULT

• Yaghoobi S, Seddighi M, Yazdi Z, Ghafouri R, Khezri MB. Comparison of Postoperative Analgesic Effect of Dexamethasone and Fentanyl Added to Lidocaine through Axillary Block in Forearm Fracture. Pain Res Treat. 2013;2013:761583. doi: 10.1155/2013/761583. Epub 2013 Dec 29.

  PMID: 24490067 RESULT

• Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.

  PMID: 23587875 RESULT

• Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.

  PMID: 20048654 RESULT

• Gonzalez AP, Bernucci F, Pham K, Correa JA, Finlayson RJ, Tran DQ. Minimum effective volume of lidocaine for double-injection ultrasound-guided axillary block. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):16-20. doi: 10.1097/AAP.0b013e3182707176.

  PMID: 23146999 RESULT

• Aliste J, Leurcharusmee P, Engsusophon P, Gordon A, Michelagnoli G, Sriparkdee C, Tiyaprasertkul W, Tran DQ, Van Zundert TC, Finlayson RJ, Tran DQH. A randomized comparison between intravenous and perineural dexamethasone for ultrasound-guided axillary block. Can J Anaesth. 2017 Jan;64(1):29-36. doi: 10.1007/s12630-016-0741-8. Epub 2016 Sep 23.

  PMID: 27663451 DERIVED

MeSH Terms

Interventions

Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• De QH Tran, MD, FRCPC

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

TH (2); CA (1)