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

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04642651

Collaborator

Beijing Jishuitan Hospital (Other)

170

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly Total Knee Arthroplasty Femoral Nerve Block Dexmedetomidine Functional Outcome	Drug: Dexmedetomidine Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 25, 2020

Actual Primary Completion Date :

Nov 22, 2021

Actual Study Completion Date :

Feb 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine group 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 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 Comparator: Control group 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 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

Arm

Intervention/Treatment

Experimental: Dexmedetomidine group

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

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 Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

Quality of life at 3 months after surgery-mental component summary score [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 Outcome Measures

Incidence of delirium within the first 3 days after surgery [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.
Length of stay in hospital after surgery [Up to 30 days after surgery]
Length of stay in hospital after surgery
Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery [Up to 30 days after surgery]
Incidence of non-delirium complications (including all-cause mortality) within 30 days after surgery
Quality of life at 3 months after surgery-physical component summary score [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).
The overall subjective sleep quality at 3 months after surgery [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.
The severity of arthritic symptoms at 3 months after surgery [At 3 months after surgery]
Assessed with WOMAC osteoarthritis index (score ranges from 0 to 96, with higher score indicating more severe symptoms).
Cognitive function at 3 months after surgery [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.
Event-free survival at 3 months after surgery [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 Outcome Measures

Pain intensity within the first 3 days after surgery [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.
Subjective sleep quality within the first 3 days after surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.