Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

NCT03629483 | Terminated Phase 4 DMC

• 1 other identifier: DEX 20180516
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium during the first 3 days after surgery

  Incidence of delirium during the first 3 days after surgery

  The first 3 days after surgery

Secondary Outcomes (11)

• Daily prevalence of delirium during postoperative days 1-3

  The first 3 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of non-delirium complications within 30 days after surgery

  Up to 30 days after surgery

• All-cause 30-day mortality

  At 30 days after surgery

• Quality of life at 30 days after surgery

  At 30 days after surgery

Other Outcomes (3)

• Sedation level during postoperative days 1-3

  The first 3 days after surgery

• Pain severity during postoperative days 1-3: NRS

  The first 3 days after surgery

• Sleep quality during postoperative days 1-3

  The first 3 days after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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).

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h (equivalent to a dexmedetomidine infusion at a rate of 0.075 ug/kg/h).

Also known as: Continuous femoral nerve block with ropivacaine

Dexmedetomidine group

Placebo DRUG

Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250 ml and placebo. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h.

Also known as: Continuous femoral nerve block with ropivacaine

Control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (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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• Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.

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MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Ropivacaine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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 and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: December 10, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share