Back to resultsDexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
Primary Purpose
Pain, Postoperative, Pain, Acute, Upper Extremity Injury
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Dexamethasone
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring nerve block adjuvants, dexamethasone, dexmedetomidine, nerve block duration
Eligibility Criteria
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
Sites / Locations
- Hospital Clínico Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Perineural dexamethasone
Perineural dexmedetomidine
Arm Description
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Outcomes
Primary Outcome Measures
Motor block duration
Elapsed time since the end of LA injection until return of hand and fingers movement
Secondary Outcome Measures
Sensory block duration
Elapsed time since the end of LA injection until return of hand and fingers sensation
Analgesic block duration
Elapsed time since the end of LA injection until first sensation of pain in surgical area
Block performance time
Elapsed time from skin desinfection until the end of LA injection
Intensity of pain during block procedure
Evaluated with a numeric rating score from 0 to 10
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points
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.
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
Perioperative glycemic levels
Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
Perioperative median artery pressure (MAP)
Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
Perioperative heart rate (HR)
Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
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.
Respiratory depression
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
Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03610893
Brief Title
Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
Official Title
A Randomized Comparison Between Perineural Dexamethasone and Perineural Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Blocks
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute, Upper Extremity Injury
Keywords
nerve block adjuvants, dexamethasone, dexmedetomidine, nerve block duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineural dexamethasone
Arm Type
Active Comparator
Arm Description
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Arm Title
Perineural dexmedetomidine
Arm Type
Active Comparator
Arm Description
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone as perineural local anesthetic adjuvant
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine as perineural local anesthetic adjuvant
Primary Outcome Measure Information:
Title
Motor block duration
Description
Elapsed time since the end of LA injection until return of hand and fingers movement
Time Frame
24 hours after block
Secondary Outcome Measure Information:
Title
Sensory block duration
Description
Elapsed time since the end of LA injection until return of hand and fingers sensation
Time Frame
24 hours after block
Title
Analgesic block duration
Description
Elapsed time since the end of LA injection until first sensation of pain in surgical area
Time Frame
24 hours after block
Title
Block performance time
Description
Elapsed time from skin desinfection until the end of LA injection
Time Frame
1 hour before surgery
Title
Intensity of pain during block procedure
Description
Evaluated with a numeric rating score from 0 to 10
Time Frame
1 hour before surgery
Title
Block onset time
Description
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
Title
Sensory and motor block score
Description
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
Title
Incidence of complete block
Description
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
Title
Perioperative glycemic levels
Description
Capillary dextrose measurements at pre block, 1 hour post-surgery and 6 hours post-surgery
Time Frame
Perioperative period
Title
Perioperative median artery pressure (MAP)
Description
Average of MAP and HR registered during preblock, intraoperative and up to 2 hours of postoperative period
Time Frame
2 hours after surgery
Title
Perioperative heart rate (HR)
Description
Average MAP registered during preblock, intraoperative and up to 2 hours of postoperative period
Time Frame
2 hours after surgery
Title
Postoperative persistent sedation
Description
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
Title
Respiratory depression
Description
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
Title
Incidence of block side effects
Description
Presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, pneumothorax, hemidiaphragmatic paralysis, Horner syndrome or hoarseness
Time Frame
2 hours after surgery
Title
Persistent neurologic deficit
Description
Presence of persistent sensory or motor postoperative deficit
Time Frame
7 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25629321
Citation
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. Erratum In: Reg Anesth Pain Med. 2015 Jul-Aug;40(4):398.
Results Reference
result
PubMed Identifier
23587875
Citation
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.
Results Reference
result
PubMed Identifier
24413428
Citation
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.
Results Reference
result
PubMed Identifier
23587874
Citation
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.
Results Reference
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PubMed Identifier
26649424
Citation
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.
Results Reference
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PubMed Identifier
27015546
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
Results Reference
derived
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Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
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