Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty

Elderly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642651
• Other study ID #: 2020-502
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 25, 2022
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Elderly
• Femoral Nerve Block
• Functional Outcome
• Total Knee Arthroplasty

Intervention

Drug:
• Dexmedetomidine
Patients in the dexmedetomidine group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and 1.0 µg/kg dexmedetomidine, in a total volume of 20 ml.
• Placebo
Patients in the control group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and normal saline, in a total volume of 20 ml.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

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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. — View 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;(5):CD009941. doi: 10.1002/14651858.CD009941.pub2. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity within the first 3 days after surgery	Pain intensity is assessed twice daily (8-10 am and 18-20 pm) with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain.	The first 3 days after surgery
Other	Subjective sleep quality within the first 3 days after surgery	Subjective sleep quality is assessed with the Numeric Rating Scale (NRS), an 11 points scale where 0=the best sleep and 10=the worst sleep.	The first 3 days after surgery
Primary	Quality of life at 3 months after surgery-mental component summary score	Quality of life is assessed with 12-item short-form (SF-12, it is summarized into physical and mental component summary scores, each ranges from 0 to 100, with higher scores indicating better quality of life).	At 3 months after surgery
Secondary	Incidence of delirium within the first 3 days after surgery	Delirium is assessed with the Three-dimensional Confusion Assessment Method (3D CAM) twice daily (8:00-10:00 and 18:00-20:00) over the first 3 postoperative hospital days. Patients with endotracheal intubation will be assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the same period.	The first 3 days after surgery
Secondary	Length of stay in hospital after surgery	Length of stay in hospital after surgery	Up to 30 days after surgery
Secondary	Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery	Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery	Up to 30 days after surgery
Secondary	Quality of life at 3 months after surgery-physical component summary score	Quality of life is assessed with 12-item short-form (SF-12, it is summarized into physical and mental component summary scores, each ranges from 0 to 100, with higher scores indicating better quality of life).	At 3 months after surgery
Secondary	The overall subjective sleep quality at 3 months after surgery	Evaluated by the Pittsburgh Sleep Quality Index, which estimates overall subjective sleep quality in the past 30 days. Overall score ranges from 0 to 21. A higher score indicates worse sleep quality, and a score greater than 5 indicates poor sleep quality.	At 3 months after surgery
Secondary	The severity of arthritic symptoms at 3 months after surgery	Assessed with WOMAC osteoarthritis index (score ranges from 0 to 96, with higher score indicating more severe symptoms).	At 3 months after surgery
Secondary	Cognitive function at 3 months after surgery	Evaluated with the modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 48, with higher score indicating better function.	At 3 months after surgery
Secondary	Event-free survival at 3 months after surgery	Time from surgery to new-onset diseases or all-cause death, whichever comes first. New-onset disease indicates those that required hospital admission and/or interventional procedure.	At 3 months after surgery