Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

P

Peking University

Status and phase

Suspended
Phase 4

Conditions

Knee Arthroplasty
Long-term Outcome
Dexmedetomidine
Nerve Block
Elderly
Postoperative Delirium

Treatments

Drug: Placebo
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03629483
DEX 20180516

Details and patient eligibility

About

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. Continuous femoral nerve block is frequently used for postoperative analgesia after total knee arthoplasty. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Full description

A growing number of elderly patients undergo total knee arthroplasty. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Dexmedetomidine has been shown to prolong the duration of nerve block without neurotoxicity and improve postoperative sleep quality. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Enrollment

736 estimated patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elderly patients (≥ 65 years but < 90 years);
  • Scheduled to undergo single total knee arthroplasty;
  • Planned to receive continuous femoral nerve block for postoperative analgesia.

Exclusion criteria

  • Refuse to participate in this study;
  • Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
  • Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
  • Preoperative hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
  • Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);
  • Preoperative 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);
  • ASA classification ≥ IV or unlikely to survive for more than 24 hours after surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

736 participants in 2 patient groups, including a placebo group

Dexmedetomidine group
Experimental group
Description:
For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours (equivalent to dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
Treatment:
Drug: Dexmedetomidine
Control group
Placebo Comparator group
Description:
For patients in the control group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and placebo (normal saline). The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours.
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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