Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
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|ClinicalTrials.gov Identifier: NCT03610893|
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : May 1, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks|
|Actual Study Start Date :||August 16, 2018|
|Actual Primary Completion Date :||April 30, 2019|
|Actual Study Completion Date :||April 30, 2019|
Active Comparator: Perineural dexamethasone
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Dexamethasone as perineural local anesthetic adjuvant
Active Comparator: Perineural dexmedetomidine
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Dexmedetomidine as perineural local anesthetic adjuvant
- Motor block duration [ Time Frame: 24 hours after block ]Elapsed time since the end of LA injection until return of hand and fingers movement
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610893
|Hospital Clínico Universidad de Chile|
|Santiago, Metropolitana, Chile, 8380456|