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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineural dexamethasone | Active Comparator | addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block |
|
| Perineural dexmedetomidine | Active Comparator | addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone as perineural local anesthetic adjuvant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Motor block duration | Elapsed time since the end of LA injection until return of hand and fingers movement | 24 hours after block |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory block duration | Elapsed time since the end of LA injection until return of hand and fingers sensation | 24 hours after block |
| Analgesic block duration | Elapsed time since the end of LA injection until first sensation of pain in surgical area |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25629321 | Result | Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210. | |
| 23587875 |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D001134 | Arm Injuries |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexmedetomidine |
| Drug |
Dexmedetomidine as perineural local anesthetic adjuvant |
|
| 24 hours after block |
| Block performance time | Elapsed time from skin desinfection until the end of LA injection | 1 hour before surgery |
| Intensity of pain during block procedure | Evaluated with a numeric rating score from 0 to 10 | 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 | 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. | 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 | 30 minutes post injection |
| Perioperative glycemic levels | Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery | Perioperative period |
| Perioperative median artery pressure (MAP) | Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period | 2 hours after surgery |
| Perioperative heart rate (HR) | Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period | 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. | 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) | 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 | 2 hours after surgery |
| Persistent neurologic deficit | Presence of persistent sensory or motor postoperative deficit | 7 days post surgery |
| Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15. |
| 24413428 | Result | Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10. |
| 23587874 | Result | Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15. |
| 26649424 | Result | Abdallah FW, Dwyer T, Chan VW, Niazi AU, Ogilvie-Harris DJ, Oldfield S, Patel R, Oh J, Brull R. IV and Perineural Dexmedetomidine Similarly Prolong the Duration of Analgesia after Interscalene Brachial Plexus Block: A Randomized, Three-arm, Triple-masked, Placebo-controlled Trial. Anesthesiology. 2016 Mar;124(3):683-95. doi: 10.1097/ALN.0000000000000983. |
| 27015546 | Result | Leurcharusmee P, Aliste J, Van Zundert TC, Engsusophon P, Arnuntasupakul V, Tiyaprasertkul W, Tangjitbampenbun A, Ah-Kye S, Finlayson RJ, Tran DQ. A Multicenter Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):328-33. doi: 10.1097/AAP.0000000000000386. |
| 27663451 | Result | Aliste J, Leurcharusmee P, Engsusophon P, Gordon A, Michelagnoli G, Sriparkdee C, Tiyaprasertkul W, Tran DQ, Van Zundert TC, Finlayson RJ, Tran DQH. A randomized comparison between intravenous and perineural dexamethasone for ultrasound-guided axillary block. Can J Anaesth. 2017 Jan;64(1):29-36. doi: 10.1007/s12630-016-0741-8. Epub 2016 Sep 23. |
| 28252523 | Result | Chong MA, Berbenetz NM, Lin C, Singh S. Perineural Versus Intravenous Dexamethasone as an Adjuvant for Peripheral Nerve Blocks: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2017 May/Jun;42(3):319-326. doi: 10.1097/AAP.0000000000000571. |
| 28178091 | Result | Hussain N, Grzywacz VP, Ferreri CA, Atrey A, Banfield L, Shaparin N, Vydyanathan A. Investigating the Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Brachial Plexus Block: A Systematic Review and Meta-Analysis of 18 Randomized Controlled Trials. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):184-196. doi: 10.1097/AAP.0000000000000564. |
| 31300595 | Derived | Aliste J, Layera S, Bravo D, Fernandez D, Jara A, Garcia A, Finlayson RJ, Tran DQ. Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100680. doi: 10.1136/rapm-2019-100680. Online ahead of print. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |