Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery

Summary

In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.

Timeline

Start

2017-09-18

Primary completion

2018-04-14

Completion

2018-10-13

Publications

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• Background 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.
• Background Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
• Background 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.
• Background Fredrickson MJ, Leightley P, Wong A, Chaddock M, Abeysekera A, Frampton C. An analysis of 1505 consecutive patients receiving continuous interscalene analgesia at home: a multicentre prospective safety study. Anaesthesia. 2016 Apr;71(4):373-9. doi: 10.1111/anae.13385. Epub 2016 Feb 5.
• Background Marhofer P, Anderl W, Heuberer P, Fritz M, Kimberger O, Marhofer D, Klug W, Blasl J. A retrospective analysis of 509 consecutive interscalene catheter insertions for ambulatory surgery. Anaesthesia. 2015 Jan;70(1):41-6. doi: 10.1111/anae.12840. Epub 2014 Sep 10.
• Background YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.
• Background Chalifoux F, Colin F, St-Pierre P, Godin N, Brulotte V. Low dose intravenous dexamethasone (4 mg and 10 mg) significantly prolongs the analgesic duration of single-shot interscalene block after arthroscopic shoulder surgery: a prospective randomized placebo-controlled study. Can J Anaesth. 2017 Mar;64(3):280-289. doi: 10.1007/s12630-016-0796-6. Epub 2017 Jan 3.
• Background Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.
• Background Webb BG, Sallay PI, McMurray SD, Misamore GW. Comparison of Interscalene Brachial Plexus Block Performed With and Without Steroids. Orthopedics. 2016 Nov 1;39(6):e1100-e1103. doi: 10.3928/01477447-20160819-02. Epub 2016 Aug 30.
• Background Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
• Background Desmet M, Vanneste B, Reynvoet M, Van Cauwelaert J, Verhelst L, Pottel H, Missant C, Van de Velde M. A randomised controlled trial of intravenous dexamethasone combined with interscalene brachial plexus blockade for shoulder surgery. Anaesthesia. 2015 Oct;70(10):1180-5. doi: 10.1111/anae.13156. Epub 2015 Jun 17.
• Background Jadon A, Dixit S, Kedia SK, Chakraborty S, Agrawal A, Sinha N. Interscalene brachial plexus block for shoulder arthroscopic surgery: Prospective randomised controlled study of effects of 0.5% ropivacaine and 0.5% ropivacaine with dexamethasone. Indian J Anaesth. 2015 Mar;59(3):171-6. doi: 10.4103/0019-5049.153039.
• Background Woo JH, Kim YJ, Kim DY, Cho S. Dose-dependency of dexamethasone on the analgesic effect of interscalene block for arthroscopic shoulder surgery using ropivacaine 0.5%: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):650-5. doi: 10.1097/EJA.0000000000000213.
• Background Fritsch G, Danninger T, Allerberger K, Tsodikov A, Felder TK, Kapeller M, Gerner P, Brummett CM. Dexmedetomidine added to ropivacaine extends the duration of interscalene brachial plexus blocks for elective shoulder surgery when compared with ropivacaine alone: a single-center, prospective, triple-blind, randomized controlled trial. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):37-47. doi: 10.1097/AAP.0000000000000033.
• Background Bengisun ZK, Ekmekci P, Akan B, Koroglu A, Tuzuner F. The effect of adding dexmedetomidine to levobupivacaine for interscalene block for postoperative pain management after arthroscopic shoulder surgery. Clin J Pain. 2014 Dec;30(12):1057-61. doi: 10.1097/AJP.0000000000000065.
• Background 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.
• Background Velazquez-Delgado E, Gaspar-Carrillo SP, Pena-Riveron AA, Mejia-Terrazas GE. Postoperative analgesia with dexmedetomidine in interscalene block. Comparative study. Rev Esp Anestesiol Reanim. 2017 Mar;64(3):137-143. doi: 10.1016/j.redar.2016.07.005. Epub 2016 Sep 9. English, Spanish.
• Background Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411.
• Background Keplinger M, Marhofer P, Kettner SC, Marhofer D, Kimberger O, Zeitlinger M. A pharmacodynamic evaluation of dexmedetomidine as an additive drug to ropivacaine for peripheral nerve blockade: A randomised, triple-blind, controlled study in volunteers. Eur J Anaesthesiol. 2015 Nov;32(11):790-6. doi: 10.1097/EJA.0000000000000246.
• Background Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
• Background Montefiore Medical Center; Bronx, New York. The Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016- [cited 2017 March 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02653144 NLM Identifier: NCT02653144
• Background B. P. Koirala Institute of Health Sciences; Dharan, Sunsari, Nepal. Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016- [cited 2017 March 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02787018 NLM Identifier: NCT02787018
• Background Government Medical College and Hospital; Department of Anaesthesia and Intensive Care, Government Medical and Hospital, Chandigarh, India. A randomised double blind study comparing dexmedetomidine with dexamethasone as an adjunct to ropivacaine in ultrasound guided interscalene block for shoulder surgery In: Clinical Trials Registry India [Internet]. New Delhi: database publisher (India). 2015- [cited 2017 March 5]. Available from: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11447 Identifier: CTRI/2015/08/006124
• Background 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.
• Background Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Rodrigues D, Amadeo RJJ, Wolfe S, Girling L, Funk F, Fidler K, Brown H, Leiter J, Old J, MacDonald P, Dufault B, Mutter TC. Analgesic duration of interscalene block after outpatient arthroscopic shoulder surgery with intravenous dexamethasone, intravenous dexmedetomidine, or their combination: a randomized-controlled trial. Can J Anaesth. 2021 Jun;68(6):835-845. doi: 10.1007/s12630-021-01942-2. Epub 2021 Feb 18.

Drugs

Indications