Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

• ClinicalTrials.gov Identifier: NCT03610893
• Recruitment Status: Completed
• First Posted: August 1, 2018
• Last Update Posted: May 1, 2019
• Sponsor: University of Chile
• Information provided by (Responsible Party): Julian Aliste, University of Chile

Tracking Information

• First Submitted Date: July 4, 2018
• First Posted Date: August 1, 2018
• Last Update Posted Date: May 1, 2019
• Actual Study Start Date: August 16, 2018
• Actual Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2018)

Motor block duration [ Time Frame: 24 hours after block ]

Elapsed time since the end of LA injection until return of hand and fingers movement

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 31, 2018)

• Sensory block duration [ Time Frame: 24 hours after block ]
  Elapsed time since the end of LA injection until return of hand and fingers sensation
• Analgesic block duration [ Time Frame: 24 hours after block ]
  Elapsed time since the end of LA injection until first sensation of pain in surgical area
• Block performance time [ Time Frame: 1 hour before surgery ]
  Elapsed time from skin desinfection until the end of LA injection
• Intensity of pain during block procedure [ Time Frame: 1 hour before surgery ]
  Evaluated with a numeric rating score from 0 to 10
• Block onset time [ Time Frame: 1 hour before surgery ]
  Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points
• Sensory and motor block score [ Time Frame: 30 minutes post injection ]
  Sensorimotor block assessed every 5 minutes until 30 minutes using a 16-point composite score evaluating sensory and motor block of musculocutaneus, 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, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch. Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Succesfull 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.
• Incidence of complete block [ Time Frame: 30 minutes post injection ]
  Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes post injection
• Perioperative glycemic levels [ Time Frame: Perioperative period ]
  Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
• Perioperative median artery pressure (MAP) [ Time Frame: 2 hours after surgery ]
  Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
• Perioperative heart rate (HR) [ Time Frame: 2 hours after surgery ]
  Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
• Postoperative persistent sedation [ Time Frame: 2 hours after surgery ]
  Persistent sedation after surgery using Ramsay sedation scale. 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.
• Respiratory depression [ Time Frame: 2 hours after surgery ]
  Low respiratory rate (lower than 8 breaths per minute) or persistent oxygen requirement (pulse oximetry lower than 90% without supplementary oxygen)
• Incidence of block side effects [ Time Frame: 2 hours after surgery ]
  Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness
• Persistent neurologic deficit [ Time Frame: 7 days post surgery ]
  Presence of persistent sensory or motor postoperative deficit

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
• Official Title: A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks

Brief Summary

When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve blocks. These drugs have important differences in terms of cost and safety profiles. This randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided infraclavicular brachial plexus blocks (ICBs).

Since analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. The protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. The equivalency margin is set at 3 hrs.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pain, Postoperative
• Pain, Acute
• Upper Extremity Injury

Intervention

• Drug: Dexamethasone
  Dexamethasone as perineural local anesthetic adjuvant
• Drug: Dexmedetomidine
  Dexmedetomidine as perineural local anesthetic adjuvant

Study Arms

• Active Comparator: Perineural dexamethasone
  addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
  Intervention: Drug: Dexamethasone
• Active Comparator: Perineural dexmedetomidine
  addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
  Intervention: Drug: Dexmedetomidine

Publications *

• 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. Erratum in: Reg Anesth Pain Med. 2015 Jul-Aug;40(4):398.
• 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.
• Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10. Review.
• Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15. Review.
• Abdallah FW, Dwyer T, Chan VW, Niazi AU, Ogilvie-Harris DJ, Oldfield S, Patel R, Oh J, Brull R. IV and Perineural Dexmedetomidine Similarly Prolong the Duration of Analgesia after Interscalene Brachial Plexus Block: A Randomized, Three-arm, Triple-masked, Placebo-controlled Trial. Anesthesiology. 2016 Mar;124(3):683-95. doi: 10.1097/ALN.0000000000000983.
• Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386.
• 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.
• Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571. Review.
• Hussain N, Grzywacz VP, Ferreri CA, Atrey A, Banfield L, Shaparin N, Vydyanathan A. Investigating the Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Brachial Plexus Block: A Systematic Review and Meta-Analysis of 18 Randomized Controlled Trials. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):184-196. doi: 10.1097/AAP.0000000000000564. Review.
• Aliste J, Layera S, Bravo D, Fernández D, Jara Á, García A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11. pii: rapm-2019-100680. doi: 10.1136/rapm-2019-100680. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2018): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 30, 2019
• Actual Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age between 18 and 75 years
• American Society of Anesthesiologists classification 1-3
• body mass index between 20 and 35

Exclusion Criteria:

• 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 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 infraclavicular region
• chronic pain syndromes requiring opioid intake at home

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT03610893
• Other Study ID Numbers: 953/18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Julian Aliste, University of Chile
• Study Sponsor: University of Chile
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Chile
• Verification Date: April 2019