Skip to main content
OpenTrials
Completed

NCT Number: NCT04642651

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Jishuitan Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dexmedetomidine hydrochloride

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.

Other names: Normal saline

Primary outcomes

  1. Quality of life at 3 months after surgery-mental component summary score

    Time frame: At 3 months after surgery

    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).

Secondary outcomes

  1. Incidence of delirium within the first 3 days after surgery

    Time frame: 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.

  2. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

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

    Time frame: Up to 30 days after surgery

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

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

    Time frame: At 3 months after surgery

    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).

  5. The overall subjective sleep quality at 3 months after surgery

    Time frame: 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.

  6. The severity of arthritic symptoms at 3 months after surgery

    Time frame: At 3 months after surgery

    Assessed with WOMAC osteoarthritis index (score ranges from 0 to 96, with higher score indicating more severe symptoms).

  7. Cognitive function at 3 months after surgery

    Time frame: 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.

  8. Event-free survival at 3 months after surgery

    Time frame: 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.

Other outcomes

  1. Pain intensity within the first 3 days after surgery

    Time frame: 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.

  2. Subjective sleep quality within the first 3 days after surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.