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

NCT04642651 | Completed Phase 4 DMC

• 1 other identifier: 2020-502
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Elderly; Total knee arthroplasty; Femoral nerve block; Dexmedetomidine; Functional outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of delirium within the first 3 days after surgery

  The first 3 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery

  Up to 30 days after surgery

• Quality of life at 3 months after surgery-physical component summary score

  At 3 months after surgery

• The overall subjective sleep quality at 3 months after surgery

  At 3 months after surgery

Other Outcomes (2)

• Pain intensity within the first 3 days after surgery

  The first 3 days after surgery

• Subjective sleep quality within the first 3 days after surgery

  The first 3 days after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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. Postoperatively, patient-controlled intravenous analgesia is provided for at least 48 hours. The formula is sufentanil (1.25 μg/ml), diluted with normal saline to 100 ml. 5-HT3 receptor antagonist is added when necessary. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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. Postoperatively, patient-controlled intravenous analgesia is provided for at least 48 hours. The formula is sufentanil (1.25 μg/ml), diluted with normal saline to 100 ml. 5-HT3 receptor antagonist is added when necessary. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine hydrochloride

Dexmedetomidine group

Placebo DRUG

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.

Also known as: Normal saline

Control group

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Related Publications (24)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 31260468 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 24, 2020
• Study Start: November 25, 2020
• Primary Completion: November 22, 2021
• Study Completion: February 25, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)