search
Back to results

Low Dose Dexamethasone in Supraclavicular Blocks

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Nerve Entrapment

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control intervention (no dexamethasone)
Peri-neural Dexamethasone 1 mg
Intravenous Dexamethasone 1 mg
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring brachial plexus, supraclavicular, duration, dexamethasone, block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult 18 - 80 years
  • BMI equal to or less than 35
  • Upper limb surgery
  • Normal pre-operative sensation in the operative limb

Exclusion Criteria:

  • Pre-operative opioid greater than 4 Tylenol #3 per day (or equivalent)
  • Pre-existing, fluctuating neurologic injury involving operative upper limb
  • Patient refusal or patient inability to provide consent
  • Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease (skin infection at site of needle insertion) as judged by the investigator or attending anesthesiologist, reason for exclusion will be recorded.
  • Patient pregnancy
  • Patient BMI > 35
  • Patient allergy to any of the drugs used in the protocol
  • Surgical concern of postoperative neurological injury from surgical manipulation.
  • Brittle diabetics
  • Other contraindication to receiving a block (coagulopathy, significant respiratory risk, etc.)
  • Surgeon refusal (e.g. concerns about compartment syndrome); reason for exclusion will be recorded

Sites / Locations

  • South Health CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control (C)

Peri-neural (N)

Intravenous

Arm Description

Control intervention (no dexamethasone)

Peri-neural Dexamethasone 1 mg

Intravenous Dexamethasone 1 mg

Outcomes

Primary Outcome Measures

Time to first sensation of pain at the surgical site.

Secondary Outcome Measures

duration of motor blockade
time (in hours) to return of full pre-operative strength in the operative limb
morphine or morphine equivalent usage in the first 48 h postoperatively
incidence of nausea and vomiting and pruritus in the first 48 h
numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7
residual paraesthesias or motor blockade at 7 days.

Full Information

First Posted
January 24, 2016
Last Updated
September 2, 2016
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT02666443
Brief Title
Low Dose Dexamethasone in Supraclavicular Blocks
Official Title
Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted side effects. Single shot blocks with local anesthetic alone usually do not last the duration of the acute post-surgical pain period. This has led to the exploration of multiple adjuvants to increase the duration of single shot blocks, the most promising adjuvant being dexamethasone. Peri-neural administration is an off-label use of dexamethasone. While no adverse events have been reported in human clinical studies, logic would dictate that we minimize the dose needed to produce the desired effect. Most studies thus far have used peri-neural dexamethasone doses ranging from 4-10 mg. However, Albrecht et al. found no difference in block duration comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block duration using doses of 1, 2 and 4 mg. Recent studies have evaluated whether systemic and peri-neural administrations of dexamethasone are equivalent, which would in turn imply a site of action. Results have been mixed. Four studies concluded peri-neural and intravenous administration are equivalent at prolonging analgesia, though one study had methodological errors, including the administration of intravenous dexamethasone to all patients. All of these studies used dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that peri-neural administration prolonged block duration whereas intravenous did not. With that, the rationale of our study is to determine if equivalent block-prolonging analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20 mL produces similar block duration to that reported in published studies using higher doses.
Detailed Description
The investigators will evaluate the block-prolonging efficacy of dexamethasone 1 mg in supraclavicular blocks. The investigators will be answering essentially two questions. First, how long do supraclavicular blocks last when low dose dexamethasone is used as an adjunct. Only one study has looked at doses this low (Liu et al. 2015). Some methodological problems with this study include evaluation of shoulder surgery using supraclavicular blocks, which may or may not cover the posterior port site; use of the endpoint of "time to first analgesic", which may or may not indicate actual block duration; and low numbers powered to 80%, which may yield spurious results. To avoid these issues the investigators chose upper limb surgery, a type of block which will definitely cover the entire surgical site, and an endpoint of time to first pain at surgical site, regardless of whether analgesic is needed. The investigators are also powering to 95% and recruiting higher numbers of patients. The second question evaluates the efficacy of 1 mg of intravenous dexamethasone. The study is powered to address this question, but in doing so is also powered adequately to address the first question. Studies to date have mixed results and methodological errors. No other studies have evaluated this dose of intravenous dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis, Nerve Entrapment, Ligament Injury
Keywords
brachial plexus, supraclavicular, duration, dexamethasone, block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (C)
Arm Type
Placebo Comparator
Arm Description
Control intervention (no dexamethasone)
Arm Title
Peri-neural (N)
Arm Type
Experimental
Arm Description
Peri-neural Dexamethasone 1 mg
Arm Title
Intravenous
Arm Type
Experimental
Arm Description
Intravenous Dexamethasone 1 mg
Intervention Type
Drug
Intervention Name(s)
Control intervention (no dexamethasone)
Other Intervention Name(s)
Control
Intervention Description
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 50 mL normal saline.
Intervention Type
Drug
Intervention Name(s)
Peri-neural Dexamethasone 1 mg
Other Intervention Name(s)
Peri-neural
Intervention Description
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL dexamethasone 1% (1 mg dexamethasone), and an intravenous solution of 50 mL normal saline.
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexamethasone 1 mg
Other Intervention Name(s)
IV
Intervention Description
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 49.9 mL normal saline with 0.1mL dexamethasone 1%
Primary Outcome Measure Information:
Title
Time to first sensation of pain at the surgical site.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
duration of motor blockade
Description
time (in hours) to return of full pre-operative strength in the operative limb
Time Frame
72 hours
Title
morphine or morphine equivalent usage in the first 48 h postoperatively
Time Frame
48 hours
Title
incidence of nausea and vomiting and pruritus in the first 48 h
Time Frame
48 hours
Title
numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7
Time Frame
7 days
Title
residual paraesthesias or motor blockade at 7 days.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult 18 - 80 years BMI equal to or less than 35 Upper limb surgery Normal pre-operative sensation in the operative limb Exclusion Criteria: Pre-operative opioid greater than 4 Tylenol #3 per day (or equivalent) Pre-existing, fluctuating neurologic injury involving operative upper limb Patient refusal or patient inability to provide consent Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease (skin infection at site of needle insertion) as judged by the investigator or attending anesthesiologist, reason for exclusion will be recorded. Patient pregnancy Patient BMI > 35 Patient allergy to any of the drugs used in the protocol Surgical concern of postoperative neurological injury from surgical manipulation. Brittle diabetics Other contraindication to receiving a block (coagulopathy, significant respiratory risk, etc.) Surgeon refusal (e.g. concerns about compartment syndrome); reason for exclusion will be recorded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan JD Brown, BMSc, MD
Phone
403-956-3883
Email
nathan.brown@albertahealthservices.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa T Jack, MD, PhD
Phone
403-956-3883
Email
melissa.jack@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan JD Brown, BMSc, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan JD Brown, BMSc MD
Phone
403-956-3883
Email
nathan.brown@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Melissa T Jack, MD PhD FRCPC
Phone
403-956-3883
Email
melissa.jack@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Shaylyn H Montgomery, MSc MD FRCPC
First Name & Middle Initial & Last Name & Degree
Mark A Kostash, MD FRCPC

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I am not sure what the entirety of a "yes" answer entails, or with whom the data would be shared. Hence, undecided.
Citations:
PubMed Identifier
20565394
Citation
Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
Results Reference
background
PubMed Identifier
25275574
Citation
Noss CD, MacKenzie LD, Kostash MA. Adjuvant dexamethasone: innovation, farce, or folly? Reg Anesth Pain Med. 2014 Nov-Dec;39(6):540-5. doi: 10.1097/AAP.0000000000000148. No abstract available.
Results Reference
background
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
background
PubMed Identifier
25774458
Citation
Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
Results Reference
background
PubMed Identifier
25123271
Citation
Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
Results Reference
background
PubMed Identifier
26207854
Citation
Knight JB, Schott NJ, Kentor ML, Williams BA. Neurotoxicity of common peripheral nerve block adjuvants. Curr Opin Anaesthesiol. 2015 Oct;28(5):598-604. doi: 10.1097/ACO.0000000000000222.
Results Reference
background
PubMed Identifier
21519308
Citation
Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
Results Reference
background
PubMed Identifier
25339320
Citation
Williams BA, Butt MT, Zeller JR, Coffee S, Pippi MA. Multimodal perineural analgesia with combined bupivacaine-clonidine-buprenorphine-dexamethasone: safe in vivo and chemically compatible in solution. Pain Med. 2015 Jan;16(1):186-98. doi: 10.1111/pme.12592. Epub 2014 Oct 23.
Results Reference
background
PubMed Identifier
8916834
Citation
Castillo J, Curley J, Hotz J, Uezono M, Tigner J, Chasin M, Wilder R, Langer R, Berde C. Glucocorticoids prolong rat sciatic nerve blockade in vivo from bupivacaine microspheres. Anesthesiology. 1996 Nov;85(5):1157-66. doi: 10.1097/00000542-199611000-00025.
Results Reference
background
PubMed Identifier
21799397
Citation
De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
Results Reference
background
PubMed Identifier
23220857
Citation
Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.
Results Reference
background
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
background
PubMed Identifier
24686045
Citation
Rahangdale R, Kendall MC, McCarthy RJ, Tureanu L, Doty R Jr, Weingart A, De Oliveira GS Jr. The effects of perineural versus intravenous dexamethasone on sciatic nerve blockade outcomes: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2014 May;118(5):1113-9. doi: 10.1213/ANE.0000000000000137.
Results Reference
background
PubMed Identifier
23698496
Citation
Fredrickson Fanzca MJ, Danesh-Clough TK, White R. Adjuvant dexamethasone for bupivacaine sciatic and ankle blocks: results from 2 randomized placebo-controlled trials. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):300-7. doi: 10.1097/AAP.0b013e318292c121.
Results Reference
background
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
background
PubMed Identifier
24817819
Citation
Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.
Results Reference
background
PubMed Identifier
25637938
Citation
Liu J, Richman KA, Grodofsky SR, Bhatt S, Huffman GR, Kelly JD 4th, Glaser DL, Elkassabany N. Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study. J Clin Anesth. 2015 May;27(3):237-42. doi: 10.1016/j.jclinane.2014.12.004. Epub 2015 Jan 28.
Results Reference
background
PubMed Identifier
26079360
Citation
Bolin ED, Wilson S. Perineural Versus Systemic Dexamethasone: Questions Remain Unanswered. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):393-4. doi: 10.1097/AAP.0000000000000262. No abstract available.
Results Reference
background
Citation
Beecroft CL, Coventry DM. Anaesthesia for shoulder surgery. Continuing Education in Anaesthesia, Critical Care & Pain 2008 ; 8: 193-98
Results Reference
background
PubMed Identifier
19282715
Citation
Perlas A, Lobo G, Lo N, Brull R, Chan VW, Karkhanis R. Ultrasound-guided supraclavicular block: outcome of 510 consecutive cases. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):171-6. doi: 10.1097/AAP.0b013e31819a3f81.
Results Reference
background
Citation
Ultrasound for Regional Anesthesia, Supraclavicular Block. 2008; http://www.usra.ca/supneedle.php accessed September 22, 2015
Results Reference
background
PubMed Identifier
21676892
Citation
Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
Results Reference
background
PubMed Identifier
18340366
Citation
Shrestha BR, Maharjan SK, Shrestha S, Gautam B, Thapa C, Thapa PB, Joshi MR. Comparative study between tramadol and dexamethasone as an admixture to bupivacaine in supraclavicular brachial plexus block. JNMA J Nepal Med Assoc. 2007 Oct-Dec;46(168):158-64.
Results Reference
background

Learn more about this trial

Low Dose Dexamethasone in Supraclavicular Blocks

We'll reach out to this number within 24 hrs