Pain Management, Peripheral Nerve Block, Sedation, Total Knee Arthroplasty
Conditions
Brief 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.
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).
Interventions
PROCEDUREperi-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
PROCEDUREpost-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
DRUGlidocaine
DEVICEultrasound
DEVICEinsulated needle (Contiplex B Braun, Melsungen, Germany)
DRUGropivacaine
DRUGsaline
Sponsors
Min Su
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major post-operative complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute post-operative Pain assessed by visual analogue scale | At 12 hours ,24hours ,48hours,72 hours post-operatively | Acute |
| Dosages of rescue medications (mg) | 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 |
| Dosages of intra-operative vasopressors,anesthetics and analgesics | during the surgery | — |
| Life quality measured by euro-quality-5 dimensions (EQ-5D) | 3 months post-operatively | EQ-5D is a commonly used scale for calibration of life quality |
| Adverse events associated with the femoral catheter | From the insertion of the catheter to 3 days post-operatively | local infection,hematoma,drop-out of the catheter,nerve injury |
Countries
China
Outcome results
None listed