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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02576015
• Other study ID #: CYYYMZK-07
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2015
• Last updated: October 14, 2015
• Start date: March 2016

Study information

• Verified date: October 2015
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chongqing Municipal Commission of Health and Family Planning:China
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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
• 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

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

Drug:
• ropivacaine

• saline

Locations

Country	Name	City	State
China	The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University	Chonqqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Min Su

Country where clinical trial is conducted

China, 

References & Publications (17)

Baldini G, Bagry H, Carli F. Depth of anesthesia with desflurane does not influence the endocrine-metabolic response to pelvic surgery. Acta Anaesthesiol Scand. 2008 Jan;52(1):99-105. Epub 2007 Nov 1. — View Citation

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. — View Citation

Gurman GM, Popescu M, Weksler N, Steiner O, Avinoah E, Porath A. Influence of the cortical electrical activity level during general anaesthesia on the severity of immediate postoperative pain in the morbidly obese. Acta Anaesthesiol Scand. 2003 Aug;47(7):804-8. — View Citation

Kertai MD, Palanca BJ, Pal N, Burnside BA, Zhang L, Sadiq F, Finkel KJ, Avidan MS; B-Unaware Study Group. Bispectral index monitoring, duration of bispectral index below 45, patient risk factors, and intermediate-term mortality after noncardiac surgery in the B-Unaware Trial. Anesthesiology. 2011 Mar;114(3):545-56. doi: 10.1097/ALN.0b013e31820c2b57. — View Citation

Kratz T, Dette F, Schmitt J, Wiesmann T, Wulf H, Zoremba M. Impact of regional femoral nerve block during general anesthesia for hip arthoplasty on blood pressure, heart rate and pain control: A randomized controlled study. Technol Health Care. 2015;23(3):313-22. doi: 10.3233/THC-150898. — View Citation

Law CJ, Jacobson GM, Kluger M, Chaddock M, Scott M, Sleigh JW. Randomized controlled trial of the effect of depth of anaesthesia on postoperative pain. Br J Anaesth. 2014 Apr;112(4):675-80. doi: 10.1093/bja/aet419. Epub 2013 Dec 8. — View Citation

Leslie K, Myles PS, Forbes A, Chan MT. The effect of bispectral index monitoring on long-term survival in the B-aware trial. Anesth Analg. 2010 Mar 1;110(3):816-22. doi: 10.1213/ANE.0b013e3181c3bfb2. Epub 2009 Nov 12. — View Citation

Lieberman JR, Freiberg AA, Lavernia CJ. Practice management strategies among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2012 Sep;27(8 Suppl):17-9.e1-6. doi: 10.1016/j.arth.2012.02.030. Epub 2012 Apr 12. — View Citation

Morin AM, Kratz CD, Eberhart LH, Dinges G, Heider E, Schwarz N, Eisenhardt G, Geldner G, Wulf H. Postoperative analgesia and functional recovery after total-knee replacement: comparison of a continuous posterior lumbar plexus (psoas compartment) block, a continuous femoral nerve block, and the combination of a continuous femoral and sciatic nerve block. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):434-45. — View Citation

Peng J, Wang SD. Effect of anesthesia combined with intercostal nerve block on analgesia for esophageal cancer after operation. Eur Rev Med Pharmacol Sci. 2015 Jun;19(12):2293-6. — View Citation

Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD003843. — View Citation

Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):266-7. doi: 10.4103/0970-9185.94920. — View Citation

Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. — View Citation

Soumpasis I, Kanakoudis F, Vretzakis G, Arnaoutoglou E, Stamatiou G, Iatrou C. Deep anaesthesia reduces postoperative analgesic requirements after major urological procedures. Eur J Anaesthesiol. 2010 Sep;27(9):801-6. doi: 10.1097/EJA.0b013e328337cbf4. — View Citation

Wegener JT, van Ooij B, van Dijk CN, Karayeva SA, Hollmann MW, Preckel B, Stevens MF. Long-term pain and functional disability after total knee arthroplasty with and without single-injection or continuous sciatic nerve block in addition to continuous femoral nerve block: a prospective, 1-year follow-up of a randomized controlled trial. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):58-63. doi: 10.1097/AAP.0b013e318272523c. — View Citation

Whitlock EL, Villafranca AJ, Lin N, Palanca BJ, Jacobsohn E, Finkel KJ, Zhang L, Burnside BA, Kaiser HA, Evers AS, Avidan MS. Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial. Anesthesiology. 2011 Dec;115(6):1209-18. doi: 10.1097/ALN.0b013e3182395dcb. — View Citation

Willingham MD, Karren E, Shanks AM, O'Connor MF, Jacobsohn E, Kheterpal S, Avidan MS. Concurrence of Intraoperative Hypotension, Low Minimum Alveolar Concentration, and Low Bispectral Index Is Associated with Postoperative Death. Anesthesiology. 2015 Oct;123(4):775-85. doi: 10.1097/ALN.0000000000000822. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acute post-operative Pain assessed by visual analogue scale	Acute	At 12 hours ,24hours ,48hours,72 hours post-operatively	No
Secondary	Dosages of rescue medications (mg)	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	No
Secondary	Dosages of intra-operative vasopressors,anesthetics and analgesics		during the surgery	No
Secondary	Life quality measured by euro-quality-5 dimensions (EQ-5D)	EQ-5D is a commonly used scale for calibration of life quality	3 months post-operatively	No
Secondary	Adverse events associated with the femoral catheter	local infection,hematoma,drop-out of the catheter,nerve injury	From the insertion of the catheter to 3 days post-operatively	Yes

External Links

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