Clinical trial NCT02576015: The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty
Official title: The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Sedation
Peripheral Nerve Block
Total Knee Arthroplasty
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Major post-operative complications
timeFrame: From the end of surgery to 30 days post-operatively
Secondary outcomes:
measure: Acute post-operative Pain assessed by visual analogue scale
timeFrame: At 12 hours ,24hours ,48hours,72 hours post-operatively
measure: Dosages of rescue medications (mg)
timeFrame: From the end of surgery to 3 days post-operatively
measure: Dosages of intra-operative vasopressors,anesthetics and analgesics
timeFrame: during the surgery
measure: Life quality measured by euro-quality-5 dimensions (EQ-5D)
timeFrame: 3 months post-operatively
measure: Adverse events associated with the femoral catheter
timeFrame: From the insertion of the catheter to 3 days post-operatively
Other outcomes:
Locations:
city: Chonqqing
country: China
facility: The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00000539-199807000-00019.
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.
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.
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. doi: 10.1016/j.rapm.2005.05.006.
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.
citation: 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.
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.
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. No abstract available.
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.
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.
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.
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. doi: 10.1002/14651858.CD003843.pub2.
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.
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. doi: 10.1034/j.1399-6576.2003.00148.x.
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.
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.
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. doi: 10.1093/bja/aeg236.