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

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.

Conditions

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

Interventions

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

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

DRUG

lidocaine

DEVICE

ultrasound

DEVICE

insulated needle (Contiplex B Braun, Melsungen, Germany)

DRUG

ropivacaine

DRUG

saline

Sponsors & Collaborators

• Min Su

  lead OTHER

Principal Investigators

• Su Min · First Affiliated Hospital of Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-03-31

Countries

• China