Back to results

Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

Primary Purpose

Elderly, Knee Arthroplasty, Nerve Block

Status

Suspended

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine

Placebo

About this trial

This is an interventional prevention trial for Elderly focused on measuring Elderly, Knee Arthroplasty, Nerve Block, Dexmedetomidine, Postoperative Delirium, Long-term Outcome

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

Peking University First Hospital
Beijing Jishuitan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm 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).

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.

Outcomes

Primary Outcome Measures

Incidence of delirium during the first 3 days after surgery

Secondary Outcome Measures

Daily prevalence of delirium during postoperative days 1-3

Length of stay in hospital after surgery

Incidence of non-delirium complications within 30 days after surgery

All-cause 30-day mortality

Quality of life 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

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

Survival rates at the end of the 1st，2nd, and 3rd years after surgery

Incidence of new-onset diseases within 3 years after surgery

Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12

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

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.

Full Information

NCT ID

NCT03629483

First Posted

August 8, 2018

Last Updated

April 19, 2022

Sponsor

Peking University First Hospital

Collaborators

Beijing Jishuitan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03629483

Brief Title

Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

Official Title

Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Suspended

Why Stopped

Trial stopped by the sponsor because of no funding.

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

December 11, 2018 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

Collaborators

Beijing Jishuitan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Continuous femoral nerve block with ropivacaine

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Continuous femoral nerve block with ropivacaine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of delirium during the first 3 days after surgery

Description

Incidence of delirium during the first 3 days after surgery

Time Frame

The first 3 days after surgery

Secondary Outcome Measure Information:

Title

Daily prevalence of delirium during postoperative days 1-3

Description

Daily prevalence of delirium during postoperative days 1-3

Time Frame

The first 3 days after surgery

Title

Length of stay in hospital after surgery

Description

Length of stay in hospital after surgery

Time Frame

Up to 30 days after surgery

Title

Incidence of non-delirium complications within 30 days after surgery

Description

Incidence of non-delirium complications within 30 days after surgery

Time Frame

Up to 30 days after surgery

Title

All-cause 30-day mortality

Description

All-cause 30-day mortality

Time Frame

At 30 days after surgery

Title

Quality of life at 30 days after surgery

Description

Time Frame

At 30 days after surgery

Title

Cognitive function at 30 days after surgery

Description

Time Frame

At 30 days after surgery

Title

Overall survival within 3 years after surgery

Description

Overall survival within 3 years after surgery

Time Frame

Up to 3 years after surgery

Title

Survival rates at the end of the 1st，2nd, and 3rd years after surgery

Description

Survival rates at the end of the 1st，2nd, and 3rd years after surgery

Time Frame

At the end of the 1st, 2nd, and 3rd years after surgery

Title

Incidence of new-onset diseases within 3 years after surgery

Description

Incidence of new-onset diseases within 3 years after surgery

Time Frame

Up to 3 years after surgery

Title

Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12

Description

Time Frame

At the end of the 1st, 2nd, and 3rd years after surgery

Title

Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery

Description

Time Frame

At the end of the 1st, 2nd, and 3rd years after surgery

Other Pre-specified Outcome Measures:

Title

Sedation level during postoperative days 1-3

Description

Sedation level during postoperative days 1-3 is assessed with the Richmond Agitation-Sedation Scale (RASS), of which the range is as follows: +4 (combative), +3 (very agitated), +2 (agitated), +1 (restless), 0 (alert and clam), -1 (drowsy), -2 (light sedation), -3 (moderate sedation), -4 (deep sedation), and -5 (unarousable).

Time Frame

The first 3 days after surgery

Title

Pain severity during postoperative days 1-3: NRS

Description

Pain severity during postoperative days 1-3 is assessed with the Numeric Rating Scale (NRS), an 11-point pain scale where 0=no pain and 10=the most severe pain.

Time Frame

The first 3 days after surgery

Title

Sleep quality during postoperative days 1-3

Description

Sleep quality during postoperative days 1-3 is assessed with the Verran and Snyder-Halpern (VSH) Sleep Scale, an 8-item questionnaire that evaluate multiple aspects of sleep during the previous night. Each item is scored in a range from 0 (very bad) to 10 (very good), and the total VSH score is determined by the summation of these scores (range 0-80). A higher total VSH score indicates a better quality of sleep.

Time Frame

The first 3 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong-Xin Wang, MD, PhD

Organizational Affiliation

Peking University First Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Beijing Jishuitan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100035

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28525512

Citation

Mu DL, Zhang DZ, Wang DX, Wang G, Li CJ, Meng ZT, Li YW, Liu C, Li XY. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017 Jun;124(6):1992-2000. doi: 10.1213/ANE.0000000000002095.

Results Reference

background

PubMed Identifier

16181163

Citation

Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.

Results Reference

background

PubMed Identifier

27542303

Citation

Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.

Results Reference

background

PubMed Identifier

29742525

Citation

Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.

Results Reference

background

PubMed Identifier

29562395

Citation

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.

Results Reference

background

PubMed Identifier

21484386

Citation

Choy WS, Lee SK, Kim KJ, Kam BS, Yang DS, Bae KW. Two continuous femoral nerve block strategies after TKA. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1901-8. doi: 10.1007/s00167-011-1510-4. Epub 2011 Apr 12.

Results Reference

background

PubMed Identifier

17027440

Citation

Duarte VM, Fallis WM, Slonowsky D, Kwarteng K, Yeung CK. Effectiveness of femoral nerve blockade for pain control after total knee arthroplasty. J Perianesth Nurs. 2006 Oct;21(5):311-6. doi: 10.1016/j.jopan.2006.05.011.

Results Reference

background

PubMed Identifier

27611039

Citation

Abdulatif M, Fawzy M, Nassar H, Hasanin A, Ollaek M, Mohamed H. The effects of perineural dexmedetomidine on the pharmacodynamic profile of femoral nerve block: a dose-finding randomised, controlled, double-blind study. Anaesthesia. 2016 Oct;71(10):1177-85. doi: 10.1111/anae.13603.

Results Reference

background

PubMed Identifier

21666435

Citation

Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.

Results Reference

background

PubMed Identifier

18567675

Citation

Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epub 2008 Jun 20.

Results Reference

background

PubMed Identifier

18719449

Citation

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.

Results Reference

background

PubMed Identifier

18480522

Citation

Behera BK, Puri GD, Ghai B. Patient-controlled epidural analgesia with fentanyl and bupivacaine provides better analgesia than intravenous morphine patient-controlled analgesia for early thoracotomy pain. J Postgrad Med. 2008 Apr-Jun;54(2):86-90. doi: 10.4103/0022-3859.40772.

Results Reference

background

PubMed Identifier

19623056

Citation

Halaszynski TM. Pain management in the elderly and cognitively impaired patient: the role of regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):594-9. doi: 10.1097/ACO.0b013e32833020dc.

Results Reference

background

PubMed Identifier

25642413

Citation

Kosar CM, Tabloski PA, Travison TG, Jones RN, Schmitt EM, Puelle MR, Inloes JB, Saczynski JS, Marcantonio ER, Meagher D, Reid MC, Inouye SK. EFFECT OF PREOPERATIVE PAIN AND DEPRESSIVE SYMPTOMS ON THE DEVELOPMENT OF POSTOPERATIVE DELIRIUM. Lancet Psychiatry. 2014 Nov;1(6):431-436. doi: 10.1016/S2215-0366(14)00006-6.

Results Reference

background

PubMed Identifier

26967259

Citation

Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.

Results Reference

background

PubMed Identifier

18577850

Citation

Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.

Results Reference

background

PubMed Identifier

22091577

Citation

Quinlan N, Rudolph JL. Postoperative delirium and functional decline after noncardiac surgery. J Am Geriatr Soc. 2011 Nov;59 Suppl 2:S301-4. doi: 10.1111/j.1532-5415.2011.03679.x.

Results Reference

background

PubMed Identifier

20497703

Citation

Shi CM, Wang DX, Chen KS, Gu XE. Incidence and risk factors of delirium in critically ill patients after non-cardiac surgery. Chin Med J (Engl). 2010 Apr 20;123(8):993-9.

Results Reference

background

PubMed Identifier

22732435

Citation

McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.

Results Reference

background

PubMed Identifier

7864702

Citation

Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461.

Results Reference

background

Learn more about this trial

Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

We'll reach out to this number within 24 hrs