Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

Phase 4

Suspended

• Conditions: Elderly; Knee Arthroplasty; Nerve Block; Dexmedetomidine; Postoperative Delirium; Long-term Outcome
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT03629483
• Lead Sponsor: Peking University First Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-11
• Study First Posted: 2018-08-14
• Study Start: 2018-12-10
• Primary Completion: 2018-12-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 736

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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.
Dexmedetomidine group	Dexmedetomidine	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).

Primary Outcome Measures

Name	Time	Method
Incidence of delirium during the first 3 days after surgery	The first 3 days after surgery	Incidence of delirium during the first 3 days after surgery

Secondary Outcome Measures

Name	Time	Method
Length of stay in hospital after surgery	Up to 30 days after surgery	Length of stay in hospital after surgery
Incidence of new-onset diseases within 3 years after surgery	Up to 3 years after surgery	Incidence of new-onset diseases within 3 years after surgery
Daily prevalence of delirium during postoperative days 1-3	The first 3 days after surgery	Daily prevalence of delirium during postoperative days 1-3
All-cause 30-day mortality	At 30 days after surgery	All-cause 30-day mortality
Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12	At the end of the 1st, 2nd, and 3rd years after surgery	Quality of life at the end of the 1st, 2nd, and 3rd years after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.
Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery	At the end of the 1st, 2nd, and 3rd years after surgery	Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery is assessed with 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 50, with higher score indicating better function.
Incidence of non-delirium complications within 30 days after surgery	Up to 30 days after surgery	Incidence of non-delirium complications within 30 days after surgery
Quality of life at 30 days after surgery	At 30 days after surgery	Quality of life at 30 days after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.
Cognitive function at 30 days after surgery	At 30 days after surgery	Cognitive function at 30 days after surgery is assessed with 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 50, with higher score indicating better function.
Overall survival within 3 years after surgery	Up to 3 years after surgery	Overall survival within 3 years after surgery
Survival rates at the end of the 1st，2nd, and 3rd years after surgery	At the end of the 1st, 2nd, and 3rd years after surgery	Survival rates at the end of the 1st，2nd, and 3rd years after surgery

Trial Locations

Locations (2)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China