Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT03610893

Collaborator

(none)

120

Enrollment

Location

Arms

8.4

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Pain, Acute Upper Extremity Injury	Drug: Dexamethasone Drug: Dexmedetomidine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 16, 2018

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Perineural dexamethasone addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block	Drug: Dexamethasone Dexamethasone as perineural local anesthetic adjuvant
Active Comparator: Perineural dexmedetomidine addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block	Drug: Dexmedetomidine Dexmedetomidine as perineural local anesthetic adjuvant

Arm

Intervention/Treatment

Active Comparator: Perineural dexamethasone

addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block

Drug: Dexamethasone

Dexamethasone as perineural local anesthetic adjuvant

Active Comparator: Perineural dexmedetomidine

addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block

Drug: Dexmedetomidine

Dexmedetomidine as perineural local anesthetic adjuvant

Outcome Measures

Primary Outcome Measures

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

Sensory block duration [24 hours after block]
Elapsed time since the end of LA injection until return of hand and fingers sensation
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
Intensity of pain during block procedure [1 hour before surgery]
Evaluated with a numeric rating score from 0 to 10
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 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.
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
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
Perioperative heart rate (HR) [2 hours after surgery]
Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
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.
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)
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
Persistent neurologic deficit [7 days post surgery]
Presence of persistent sensory or motor postoperative deficit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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