Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery
NCT ID: NCT02426736
Last Updated: 2017-10-26
Study Results
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Basic Information
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COMPLETED
PHASE4
280 participants
INTERVENTIONAL
2015-06-25
2017-01-12
Brief Summary
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Detailed Description
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Dexamethasone is the most promising of these adjuncts, with both perineural and intravenous administration consistently resulting in increased analgesic duration, by as much as two-fold. Nevertheless, it would seem prudent to administer perineural adjuncts at the lowest effective dose and only if they offer significant benefit over other routes of administration.
The multiple small clinical studies published to date have used dexamethasone doses between 4 and 10mg for both intravenous and perineural routes. Attributing differences in results between any of these studies to the dose and route of dexamethasone administered is not possible due to differences in drugs, doses, study populations and methodology. Most importantly, no study has compared two different doses of dexamethasone and the only two studies that compared the intravenous and perineural routes arrived at different conclusions. Thus, the effect of dexamethasone dose and route on the analgesic duration of interscalene block remains unclear, with multiple recent editorials and meta-analyses calling for further study. In light of these gaps in the evidence, a trial elucidating the effect of dose and route of administration of dexamethasone on analgesic duration of ISB is required. This is the focus of our proposed study.
OBJECTIVES AND HYPOTHESES In this factorial design study of outpatients undergoing elective arthroscopic shoulder surgery with interscalene brachial plexus block (ISB), the investigators will compare perineural and intravenous administration of dexamethasone at high (8mg) and low (4mg) doses. The investigators hypothesize that high doses and the perineural route will provide significantly longer duration of analgesia, without significant statistical interaction between dose and route of administration.
METHODS This single-centre, factorial design, double-blinded, randomized controlled superiority trial has four parallel groups and 1:1:1:1 randomization. Consenting and eligible adult ambulatory patients undergoing arthroscopic shoulder surgery will receive preoperative, ultrasound guided ISB with 30 millilitres (mL) of 0.5% bupivacaine and 4mg or 8mg of preservative free dexamethasone either intravenous or perineural. The remainder of the intraoperative and postoperative care is at the discretion of the attending anesthesiologist and surgeon. Based on previous work, with 70 patients per group, the study is at least 90% powered to detect a 3 hour difference in analgesia for dose or route, and a 4 hour synergistic interaction, even with a 5% attrition rate. Outcomes will be assessed by chart review and telephone follow up on postoperative day one, postoperative day 2 (if necessary), and postoperative day 14.
An interim analysis of group standard deviations only will occur after 100 patients have completed the study to determine if the original power calculations were accurate, and if testing for the interaction effect is feasible within the planned sample size of 280 participants. If testing for the interaction of dose and route is not feasible, a new study sample size will be determined, based on the number of participants needed to have 90% power to test the two main effects.
The primary outcome analysis will analyze by intention to treat only those patients who were randomized and did receive an attempt at an interscalene block. A secondary analysis will exclude patients who had a "failed" inter scalene block in the post anesthesia care unit. A tertiary analysis will be a multivariable analysis adjusted for demographics, preoperative naproxen use, use of general anesthesia, cumulative analgesic use and failed inter scalene block.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Low dose intravenous dexamethasone
4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Dexamethasone
Bupivacaine
Interscalene brachial plexus block
Performed with real time ultrasound guidance.
High dose intravenous dexamethasone
8 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Dexamethasone
Bupivacaine
Interscalene brachial plexus block
Performed with real time ultrasound guidance.
Low dose perineurial dexamethasone
4 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Dexamethasone
Bupivacaine
Interscalene brachial plexus block
Performed with real time ultrasound guidance.
High dose perineurial dexamethasone
8 milligrams dexamethasone administered once perineurally with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block
Dexamethasone
Bupivacaine
Interscalene brachial plexus block
Performed with real time ultrasound guidance.
Interventions
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Dexamethasone
Bupivacaine
Interscalene brachial plexus block
Performed with real time ultrasound guidance.
Eligibility Criteria
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Inclusion Criteria
* Including rotator cuff repair
* Stabilization procedures
* Acromioplasty
* Debridement and distal clavicle excision
Exclusion Criteria
* Pregnancy
* Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
* Sensitivity to local anesthetics or dexamethasone
* Severe chronic obstructive pulmonary disease
* Contralateral vocal cord paralysis
* Contralateral diaphragmatic paralysis
* Surgical limb brachial plexus neuropathy
* Interscalene block site infection
* Systemic glucocorticoids in the last 2 weeks
* Epidural or intraarticular steroid injection in the past 3 months
* Chronic opioid use defined as daily use for the last two weeks
* International normalized ratio (INR) \> 1.5
* Active peptic ulcer disease
* End-stage renal disease
* Cirrhotic liver disease
* Previous participation in the study.
18 Years
ALL
No
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Thomas Mutter
Assistant Professor of Anesthesia
Principal Investigators
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Thomas C Mutter, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
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Pan Am Surgical Centre
Winnipeg, Manitoba, Canada
Countries
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References
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Hughes MS, Matava MJ, Wright RW, Brophy RH, Smith MV. Interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review. J Bone Joint Surg Am. 2013 Jul 17;95(14):1318-24. doi: 10.2106/JBJS.L.01116. No abstract available.
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.
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Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
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.
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Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
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.
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.
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Latham JM, Fraser RD, Moore RJ, Blumbergs PC, Bogduk N. The pathologic effects of intrathecal betamethasone. Spine (Phila Pa 1976). 1997 Jul 15;22(14):1558-62. doi: 10.1097/00007632-199707150-00004.
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.
Sondekoppam RV, Uppal V, Ganapathy S. Intravenous or perineural dexamethasone for interscalene brachial plexus block: the equivalence not yet proven. Br J Anaesth. 2014 Jan;112(1):175-6. doi: 10.1093/bja/aet454. No abstract available.
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Martinez V, Fletcher D. Dexamethasone and peripheral nerve blocks: on the nerve or intravenous? Br J Anaesth. 2014 Sep;113(3):338-40. doi: 10.1093/bja/aeu144. Epub 2014 Jun 6. No abstract available.
Albrecht E, Kern C, Kirkham KR. Perineural vs intravenous administration of dexamethasone: more data are available. Br J Anaesth. 2015 Jan;114(1):160. doi: 10.1093/bja/aeu421. No abstract available.
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Holland D, Amadeo RJJ, Wolfe S, Girling L, Funk F, Collister M, Czaplinski E, Ferguson C, Leiter J, Old J, MacDonald P, Dufault B, Mutter TC. Effect of dexamethasone dose and route on the duration of interscalene brachial plexus block for outpatient arthroscopic shoulder surgery: a randomized controlled trial. Can J Anaesth. 2018 Jan;65(1):34-45. doi: 10.1007/s12630-017-0989-7. Epub 2017 Nov 10.
Other Identifiers
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B2015:016
Identifier Type: -
Identifier Source: org_study_id