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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03610893
Other study ID # 953/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2018
Est. completion date April 30, 2019

Study information

Verified date April 2019
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Chile Hospital Clínico Universidad de Chile Santiago Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (9)

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. — View Citation

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, — View Citation

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, doubl — View Citation

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 bl — View Citation

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 1 — View Citation

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. Revi — View Citation

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 — View Citation

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 Controlle — View Citation

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 I — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Motor block duration Elapsed time since the end of LA injection until return of hand and fingers movement 24 hours after block
Secondary Sensory block duration Elapsed time since the end of LA injection until return of hand and fingers sensation 24 hours after block
Secondary Analgesic block duration Elapsed time since the end of LA injection until first sensation of pain in surgical area 24 hours after block
Secondary Block performance time Elapsed time from skin desinfection until the end of LA injection 1 hour before surgery
Secondary Intensity of pain during block procedure Evaluated with a numeric rating score from 0 to 10 1 hour before surgery
Secondary Block onset time Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points 1 hour before surgery
Secondary Sensory and motor block score 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.
30 minutes post injection
Secondary 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 post injection 30 minutes post injection
Secondary Perioperative glycemic levels Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery Perioperative period
Secondary Perioperative median artery pressure (MAP) Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period 2 hours after surgery
Secondary Perioperative heart rate (HR) Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period 2 hours after surgery
Secondary Postoperative persistent sedation 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.
2 hours after surgery
Secondary Respiratory depression Low respiratory rate (lower than 8 breaths per minute) or persistent oxygen requirement (pulse oximetry lower than 90% without supplementary oxygen) 2 hours after surgery
Secondary Incidence of block side effects Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness 2 hours after surgery
Secondary Persistent neurologic deficit Presence of persistent sensory or motor postoperative deficit 7 days post surgery
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