Pain, Acute, Pain, Postoperative, Upper Extremity Injury
Conditions
Keywords
nerve block adjuvants, dexamethasone, dexmedetomidine, nerve block duration
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.
Interventions
DRUGDexamethasone
Dexamethasone as perineural local anesthetic adjuvant
DRUGDexmedetomidine
Dexmedetomidine as perineural local anesthetic adjuvant
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor block duration | 24 hours after block | Elapsed time since the end of LA injection until return of hand and fingers movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sensory block duration | 24 hours after block | Elapsed time since the end of LA injection until return of hand and fingers sensation |
| 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 |
| Perioperative glycemic levels | Perioperative period | Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery |
Countries
Chile
Outcome results
None listed