An interventional study of Dexamethasone and Dexmedetomidine in Pain, Postoperative, Pain, Acute and Upper Extremity Injury, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Drug: Dexamethasone
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Drug: Dexmedetomidine
Dexamethasone as perineural local anesthetic adjuvant
Dexmedetomidine as perineural local anesthetic adjuvant
Motor block duration
Elapsed time since the end of LA injection until return of hand and fingers movement
Time frame: 24 hours after block
Sensory block duration
Elapsed time since the end of LA injection until return of hand and fingers sensation
Time frame: 24 hours after block
Analgesic block duration
Elapsed time since the end of LA injection until first sensation of pain in surgical area
Time frame: 24 hours after block
Block performance time
Elapsed time from skin desinfection until the end of LA injection
Time frame: 1 hour before surgery
Intensity of pain during block procedure
Evaluated with a numeric rating score from 0 to 10
Time frame: 1 hour before surgery
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points
Time frame: 1 hour before surgery
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.
Time frame: 30 minutes post injection
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
Time frame: 30 minutes post injection
Perioperative glycemic levels
Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
Time frame: Perioperative period
Perioperative median artery pressure (MAP)
Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
Time frame: 2 hours after surgery
Perioperative heart rate (HR)
Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
Time frame: 2 hours after surgery
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.
Time frame: 2 hours after surgery
Respiratory depression
Low respiratory rate (lower than 8 breaths per minute) or persistent oxygen requirement (pulse oximetry lower than 90% without supplementary oxygen)
Time frame: 2 hours after surgery
Incidence of block side effects
Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness
Time frame: 2 hours after surgery
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit
Time frame: 7 days post surgery
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Chile