Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

Not Applicable

Completed

• Conditions: Upper Extremity Injury; Pain, Acute; Pain, Postoperative
• Interventions: Drug: Dexamethasone; Drug: Dexmedetomidine

• Registration Number: NCT03610893
• Lead Sponsor: University of Chile

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 available

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Study Start: 2018-08-16
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineural dexamethasone	Dexamethasone	addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Perineural dexmedetomidine	Dexmedetomidine	addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block

Primary Outcome Measures

Name	Time	Method
Motor block duration	24 hours after block	Elapsed time since the end of LA injection until return of hand and fingers movement

Secondary Outcome Measures

Name	Time	Method
Analgesic block duration	24 hours after block	Elapsed time since the end of LA injection until first sensation of pain in surgical area
Block performance time	1 hour before surgery	Elapsed time from skin desinfection until the end of LA injection
Incidence of complete block	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
Block onset time	1 hour before surgery	Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points
Sensory block duration	24 hours after block	Elapsed time since the end of LA injection until return of hand and fingers sensation
Perioperative glycemic levels	Perioperative period	Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
Perioperative median artery pressure (MAP)	2 hours after surgery	Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
Intensity of pain during block procedure	1 hour before surgery	Evaluated with a numeric rating score from 0 to 10
Respiratory depression	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)
Sensory and motor block score	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.
Postoperative persistent sedation	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.
Persistent neurologic deficit	7 days post surgery	Presence of persistent sensory or motor postoperative deficit
Perioperative heart rate (HR)	2 hours after surgery	Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
Incidence of block side effects	2 hours after surgery	Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitana, Chile