The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty
NCT ID: NCT02576015
Last Updated: 2015-10-15
Study Results
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Basic Information
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UNKNOWN
NA
380 participants
INTERVENTIONAL
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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
lidocaine
ultrasound
insulated needle (Contiplex B Braun, Melsungen, Germany)
ropivacaine
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).
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
ultrasound
ropivacaine
saline
Interventions
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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
lidocaine
ultrasound
insulated needle (Contiplex B Braun, Melsungen, Germany)
ropivacaine
saline
Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive selective unilateral knee replacement.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Min Su
OTHER
Responsible Party
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Min Su
Chief of the Departmemt of Anesthesiology
Principal Investigators
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Su Min
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Locations
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The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University
Chonqqing, Chongqing Municipality, China
Countries
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Facility Contacts
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References
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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. doi: 10.1097/00000539-199807000-00019.
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.
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.
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. doi: 10.1016/j.rapm.2005.05.006.
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.
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. doi: 10.1111/j.1399-6576.2007.01470.x. Epub 2007 Nov 1.
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.
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. No abstract available.
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.
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.
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.
Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003843. doi: 10.1002/14651858.CD003843.pub2.
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.
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. doi: 10.1034/j.1399-6576.2003.00148.x.
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.
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.
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.
Related Links
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CONsolidated Standards of Reporting Trials he Consort Group aimed at transparent reporting of the trial,"
Other Identifiers
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CYYYMZK-07
Identifier Type: -
Identifier Source: org_study_id
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