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

October 14, 2015 updated by: Min Su
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chonqqing, Chongqing, China, 400016
        • The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women over the 18 years and younger than 80 years old
  • Scheduled to receive selective unilateral knee replacement.

Exclusion Criteria:

  • Bilateral knee replacement
  • The secondary knee revision and knee surgery not interfering with articular joint cavity (wound debridement and suture)
  • American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade
  • Body mass index higher than 35
  • Coagulation dysfunction, which is assessed by activated partial thromboplastin time (APTT) higher than the upper limit by 10s; prothrombin time (PT) higher than the upper limit by 5s; International Normalized Ratio (INR) higher than 1.3, or any of criteria met above;
  • Pre-operative hypoxia (SpO2< 90% or PO2<60 mmHg)
  • Pre-operative hypercapnia (PCO2> 50 mmHg)
  • Local infection of puncture sites
  • Neurological diseases and pre-operative psychological disorders
  • Uncontrolled general infection
  • Intra-operative cardiac arrest.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group L
Participants in group L will receive a single injection for femoral nerve block combined with continuous femoral nerve block intra-operatively. The femoral nerve block will be performed before the induction of anesthesia on the leg to be operated. Then the patients were given the 2% lidocaine 10 ml and 1% ropivacaine 10 ml as initial dose,then,the patients will receive a continuous infusion of 0.15% ropivacaine at 15 ml/h.Intra-operatively, bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 50-60.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min).
Device: ultrasound
Drug: ropivacaine
Drug: lidocaine
Procedure: peri-operative continuous femoral nerve block with light sedation
this technique will be administered to participants in group L .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher &Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block intra-operatively and post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 50-60 with BIS monitoring
Device: insulated needle (Contiplex B Braun, Melsungen, Germany)
Sham Comparator: Group D
Participants in group D will receive the placement of femoral nerve catheter preoperatively. The same dose of 0.9% saline was injected and infused as group L intra-operatively. Bispectral index score (BIS) was titrated with the adjusting of desflurane to maintain the index between 30-40.After the surgery,these patients will receive continuous femoral nerve analgesia till 3 days post-operatively( the loading dose was set at 5 ml of 0.15% ropivacaine followed by an infusion of 0.15% ropivacaine at 5 ml/h, with bolus of 5 ml and the lock time of 30 min).
Device: ultrasound
Drug: ropivacaine
Drug: saline
Procedure: post-operative continuous femoral nerve block
this technique will be administered to participants in group D .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher &Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 30-40 with BIS monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major post-operative complications
Time Frame: From the end of surgery to 30 days post-operatively
Major post-operative complications summed the incidence of major complications post-operatively( (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),participants with at least one episode of the complications will be calculated as participants with complications,both the number of participants and number of events will be calculated.
From the end of surgery to 30 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute post-operative Pain assessed by visual analogue scale
Time Frame: At 12 hours ,24hours ,48hours,72 hours post-operatively
Acute
At 12 hours ,24hours ,48hours,72 hours post-operatively
Dosages of rescue medications (mg)
Time Frame: From the end of surgery to 3 days post-operatively
the dosages of tramadol,pethidine and Parecoxib during the use of patient controlled analgesia (PCA) post-operatively
From the end of surgery to 3 days post-operatively
Dosages of intra-operative vasopressors,anesthetics and analgesics
Time Frame: during the surgery
during the surgery
Life quality measured by euro-quality-5 dimensions (EQ-5D)
Time Frame: 3 months post-operatively
EQ-5D is a commonly used scale for calibration of life quality
3 months post-operatively
Adverse events associated with the femoral catheter
Time Frame: From the insertion of the catheter to 3 days post-operatively
local infection,hematoma,drop-out of the catheter,nerve injury
From the insertion of the catheter to 3 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min Su

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYYYMZK-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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