The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title: The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty

Status Not yet recruiting

Clinical Trial Summary

The interaction of analgesia and sedation ot their effect on the prognosis of surgical patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia and sedation to improve the prognosis of surgical patients is still a mystery.Intra-operative nerve block provided regional analgesia of the operated knee, which reduced the dosages of sedatives and analgesics.Based on a pilot study,the investigators found a decrease of post-operative adverse composite outcomes with the use of continuous femoral nerve block (2% versus 7%) ,therefore, the investigators postulate that general analgesia with lighter sedation in combination with peripheral nerve block could reduce the post-operative morbidity compared with deeper sedation.This randomized controlled trial is designed to test this hypothesis in patients receiving unilateral knee arthroplasty.

Clinical Trial Description

This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement.This study is designed as a randomized controlled trial to compare intra-operative continuous femoral nerve block combined with lighter anesthetic depth (group L) with deeper anesthetic depth (group D) monitored by bispectral index (BIS). All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study.The following outcomes will be assessed:post-operative major complications (post-operative pulmonary infection,need of mechanical respiratory support,myocardio-infarction,deep venous thrombosis, pulmonary embolism, stroke, poor wound healing,all-cause post-operative death within 30 days).Secondary Outcomes included :acute post-operative pain assessed by visual analogue scale and dosages of rescue medications;Dosages of intra-operative vasopressors,anesthetics and analgesics;Life quality measured by EQ-5D questionnaire 3 months post-operatively;adverse events associated with the femoral catheter (displacement, infection, hematoma,drop-out of catheter). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Management
• Peripheral Nerve Block
• Sedation
• Total Knee Arthroplasty

• NCT number: NCT02576015
• Study type: Interventional
• Source: First Affiliated Hospital of Chongqing Medical University
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2016