Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT03542981 - Interferential Current Therapy After Total Knee Arthroplasty N/A
Recruiting NCT04458480 - Effect of Fast Inpatient Rehabilitation After TKA
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Recruiting NCT05391828 - Persona MC vs PS RCT With ROSA N/A
Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Withdrawn NCT02495805 - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty N/A
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Withdrawn NCT01511211 - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic Phase 4
Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
Not yet recruiting NCT00958945 - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements N/A
Completed NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty Phase 4
Completed NCT00761956 - A Study to Compare the NexGen CR and CR-Flex Knee Implants N/A
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
Recruiting NCT05962970 - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty N/A
Completed NCT03317834 - Navio With Total Knee Arthroplasty
Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A