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

NCT02576015 | Unknown

• 1 other identifier: CYYYMZK-07
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major post-operative complications

  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 Outcomes (5)

• Acute post-operative Pain assessed by visual analogue scale

  At 12 hours ,24hours ,48hours,72 hours post-operatively

• Dosages of rescue medications (mg)

  From the end of surgery to 3 days 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

• Adverse events associated with the femoral catheter

  From the insertion of the catheter to 3 days post-operatively

Study Arms (2)

Group L

EXPERIMENTAL

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).

Procedure: peri-operative continuous femoral nerve block with light sedation; Drug: lidocaine; Device: ultrasound; Device: insulated needle (Contiplex B Braun, Melsungen, Germany); Drug: ropivacaine

Group D

SHAM COMPARATOR

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).

Procedure: post-operative continuous femoral nerve block; Device: ultrasound; Drug: ropivacaine; Drug: saline

Interventions

peri-operative continuous femoral nerve block with light sedation PROCEDURE

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

Group L

post-operative continuous femoral nerve block PROCEDURE

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

Group D

lidocaine DRUG

Group L

ultrasound DEVICE

Group D; Group L

insulated needle (Contiplex B Braun, Melsungen, Germany) DEVICE

Group L

ropivacaine DRUG

Group D; Group L

saline DRUG

Group D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University

Chonqqing, Chongqing Municipality, 400016, China

Location

Related Publications (17)

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• De Baerdemaeker LE, Struys MM, Jacobs S, Den Blauwen NM, Bossuyt GR, Pattyn P, Mortier EP. Optimization of desflurane administration in morbidly obese patients: a comparison with sevoflurane using an 'inhalation bolus' technique. Br J Anaesth. 2003 Nov;91(5):638-50. doi: 10.1093/bja/aeg236.

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Related Links

• CONsolidated Standards of Reporting Trials he Consort Group aimed at transparent reporting of the trial,"

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Ultrasonography; Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Su Min

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Departmemt of Anesthesiology

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

CN (1)