Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

Pain, Postoperative Clinical Trial

Official title:

A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610893
• Other study ID #: 953/18
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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