Clinical trial NCT04642651: Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty
Official title: Impacts of Dexmedetomidine as an Adjuvant for Femoral Nerve Block on Functional Recovery in Aged Patients After Total Knee Arthroplasty: a Randomized, Double-blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elderly
Total Knee Arthroplasty
Femoral Nerve Block
Dexmedetomidine
Functional Outcome
Keywords: Elderly
Total knee arthroplasty
Femoral nerve block
Dexmedetomidine
Functional outcome
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
First posted: 2020-11-24
Enrollment: 170
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after total knee arthroplasty (TKA). Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve functional recovery in aged patients after TKA.

Detailed description: Many patients following total knee arthroplasty (TKA) complain moderate to severe postoperative pain. Multimodal analgesia, a combination of different techniques and analgesic agents, plays an increasingly important role to relieve pain after TKA. Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after TKA. But local anesthetics alone often exert limited potency of analgesia and are insufficient to avoid supplemental opioid usage. Dexmedetomidine, a selective alpha 2-adrenergic receptor agonist, is widely used in clinical settings due to its properties of sedation, anxiolysis, analgesia, and sleep promotion. Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve the functional recovery in aged patients after TKA.

Eligibility criteria: Inclusion Criteria:

* Age ≥65 years but \<90 years;
* Scheduled to undergo unilateral total knee arthroplasty;
* Planned to use femoral nerve block and patient-controlled intravenous analgesia (PCIA) for multimodal analgesia.

Exclusion Criteria:

* Scheduled for bilateral total knee arthroplasty or revision surgery;
* Contraindications to femoral nerve block;
* Preoperative history of schizophrenia, myasthenia gravis, inability to communicate because of coma, severe dementia, or language barriers;
* Preoperative history of hemorrhagic disease or coagulopathy;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery), or American Society of Anesthesiologists physical status \>III;
* Preexistent delirium (diagnosed by Three-Dimensional Confusion Assessment Method);
* Under treatment with dexmedetomidine or clonidine.

Primary outcomes:
measure: Quality of life at 3 months after surgery-mental component summary score
timeFrame: At 3 months after surgery
Secondary outcomes:
measure: Incidence of delirium within the first 3 days after surgery
timeFrame: The first 3 days after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Quality of life at 3 months after surgery-physical component summary score
timeFrame: At 3 months after surgery
measure: The overall subjective sleep quality at 3 months after surgery
timeFrame: At 3 months after surgery
measure: The severity of arthritic symptoms at 3 months after surgery
timeFrame: At 3 months after surgery
measure: Cognitive function at 3 months after surgery
timeFrame: At 3 months after surgery
measure: Event-free survival at 3 months after surgery
timeFrame: At 3 months after surgery
Other outcomes:
measure: Pain intensity within the first 3 days after surgery
timeFrame: The first 3 days after surgery
measure: Subjective sleep quality within the first 3 days after surgery
timeFrame: The first 3 days after surgery
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
citation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
citation: Bergeron SG, Kardash KJ, Huk OL, Zukor DJ, Antoniou J. Functional outcome of femoral versus obturator nerve block after total knee arthroplasty. Clin Orthop Relat Res. 2009 Jun;467(6):1458-62. doi: 10.1007/s11999-009-0732-y. Epub 2009 Feb 18.
citation: Dixit V, Fathima S, Walsh SM, Seviciu A, Schwendt I, Spittler KH, Briggs D. Effectiveness of continuous versus single injection femoral nerve block for total knee arthroplasty: A double blinded, randomized trial. Knee. 2018 Aug;25(4):623-630. doi: 10.1016/j.knee.2018.04.001. Epub 2018 Apr 26.
citation: Chan EY, Fransen M, Parker DA, Assam PN, Chua N. Femoral nerve blocks for acute postoperative pain after knee replacement surgery. Cochrane Database Syst Rev. 2014 May 13;2014(5):CD009941. doi: 10.1002/14651858.CD009941.pub2.
citation: Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013 Jun;47(6):869-76. doi: 10.1345/aph.1AR708.
citation: Szumita PM, Baroletti SA, Anger KE, Wechsler ME. Sedation and analgesia in the intensive care unit: evaluating the role of dexmedetomidine. Am J Health Syst Pharm. 2007 Jan 1;64(1):37-44. doi: 10.2146/ajhp050508.
citation: Arcangeli A, D'Alo C, Gaspari R. Dexmedetomidine use in general anaesthesia. Curr Drug Targets. 2009 Aug;10(8):687-95. doi: 10.2174/138945009788982423.
citation: Peng K, Liu HY, Wu SR, Cheng H, Ji FH. Effects of Combining Dexmedetomidine and Opioids for Postoperative Intravenous Patient-controlled Analgesia: A Systematic Review and Meta-analysis. Clin J Pain. 2015 Dec;31(12):1097-104. doi: 10.1097/AJP.0000000000000219.
citation: Skrobik Y, Duprey MS, Hill NS, Devlin JW. Low-Dose Nocturnal Dexmedetomidine Prevents ICU Delirium. A Randomized, Placebo-controlled Trial. Am J Respir Crit Care Med. 2018 May 1;197(9):1147-1156. doi: 10.1164/rccm.201710-1995OC.
citation: Deiner S, Luo X, Lin HM, Sessler DI, Saager L, Sieber FE, Lee HB, Sano M; and the Dexlirium Writing Group; Jankowski C, Bergese SD, Candiotti K, Flaherty JH, Arora H, Shander A, Rock P. Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Aug 16;152(8):e171505. doi: 10.1001/jamasurg.2017.1505. Epub 2017 Aug 16.
citation: Wu M, Liang Y, Dai Z, Wang S. Perioperative dexmedetomidine reduces delirium after cardiac surgery: A meta-analysis of randomized controlled trials. J Clin Anesth. 2018 Nov;50:33-42. doi: 10.1016/j.jclinane.2018.06.045. Epub 2018 Jun 27.
citation: Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
citation: Alexopoulou C, Kondili E, Diamantaki E, Psarologakis C, Kokkini S, Bolaki M, Georgopoulos D. Effects of dexmedetomidine on sleep quality in critically ill patients: a pilot study. Anesthesiology. 2014 Oct;121(4):801-7. doi: 10.1097/ALN.0000000000000361.
citation: Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
citation: 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.
citation: Schnabel A, Reichl SU, Weibel S, Kranke P, Zahn PK, Pogatzki-Zahn EM, Meyer-Friessem CH. Efficacy and safety of dexmedetomidine in peripheral nerve blocks: A meta-analysis and trial sequential analysis. Eur J Anaesthesiol. 2018 Oct;35(10):745-758. doi: 10.1097/EJA.0000000000000870.
citation: Goyal R, Mittal G, Yadav AK, Sethi R, Chattopadhyay A. Adductor canal block for post-operative analgesia after simultaneous bilateral total knee replacement: A randomised controlled trial to study the effect of addition of dexmedetomidine to ropivacaine. Indian J Anaesth. 2017 Nov;61(11):903-909. doi: 10.4103/ija.IJA_277_17.
citation: Malhotra RK, Johnstone C, Banerjee A. Dexmedetomidine in peripheral and neuraxial block: a meta-analysis. Br J Anaesth. 2014 Feb;112(2):390-1. doi: 10.1093/bja/aet568. No abstract available.
citation: Li J, Wang H, Dong B, Ma J, Wu X. Adding dexmedetomidine to ropivacaine for femoral nerve block inhibits local inflammatory response. Minerva Anestesiol. 2017 Jun;83(6):590-597. doi: 10.23736/S0375-9393.17.11430-6. Epub 2017 Jan 20.
citation: Packiasabapathy SK, Kashyap L, Arora MK, Batra RK, Mohan VK, Prasad G, Yadav CS. Effect of dexmedetomidine as an adjuvant to bupivacaine in femoral nerve block for perioperative analgesia in patients undergoing total knee replacement arthroplasty: A dose-response study. Saudi J Anaesth. 2017 Jul-Sep;11(3):293-298. doi: 10.4103/sja.SJA_624_16.
citation: Wang XL, Wang J, Mu DL, Wang DX. [Dexmedetomidine combined with ropivacaine for continuous femoral nerve block improved postoperative sleep quality in elderly patients after total knee arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):728-732. doi: 10.3760/cma.j.issn.0376-2491.2018.10.003. Chinese.
citation: Zhao ZF, Du L, Wang DX. Effects of dexmedetomidine as a perineural adjuvant for femoral nerve block: A systematic review and meta-analysis. PLoS One. 2020 Oct 19;15(10):e0240561. doi: 10.1371/journal.pone.0240561. eCollection 2020.
citation: Meng ZT, Cui F, Li XY, Wang DX. Epidural morphine improves postoperative analgesia in patients after total knee arthroplasty: A randomized controlled trial. PLoS One. 2019 Jul 1;14(7):e0219116. doi: 10.1371/journal.pone.0219116. eCollection 2019.