Continuous Femoral Nerve Block Versus Local-wound Infiltration Analgesia For Patients Receiving Total Knee Arthroplasty --- A Randomized Controlled Trial

NCT02284620 | Unknown Phase 4

• 1 other identifier: CYYYMZ-001
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative pain after total knee arthroplasty is usually severe and impair the functional recovery of operated joints.The purpose of this study is to determine whether post-operative continuous femoral nerve block analgesia is superior to local wound infiltration combined with intravenous patient controlled analgesia in improving joint function and reducing the incidence of chronic post-surgical pain (CPSP).

Conditions

Postoperative Pain; Total Knee Arthroplasty

Keywords

anesthesia; nerve block; infltration

Outcome Measures

Primary Outcomes (1)

• chronic moderate-to-severe post-surgical pain

  chronic moderate-to-severe post-surgical pain will be measured as more than 3 by numerical rating scale for pain

  3 months post-operatively

Secondary Outcomes (5)

• acute pain post-operatively

  Post-operative day 1 to 3

• Analgesic Rescue

  Post-operative day 1 to 3

• Knee function

  3 months ,6 months and 12 months post-operatively

• Life Quality

  3 months ,6 months and 12 months post-operatively

• Adverse events associated with post-operative analgesia

  From surgey to discharge of hospital

Study Arms (2)

CFNB group

EXPERIMENTAL

Particiants in this group will receive a single injection for femoral nerve block intra-operatively combined continuous femoral nerve block post-operatively. This technique will be guided by ultrasound and nerve stimulator.The regimen is a loading dose of 0.8% ropivacaine 30 ml intra-operatively and 0.15% ropivacaine 300ml in the form of continuous femoral nerve block post-operatively.

Procedure: CFNB group

LWI group

ACTIVE COMPARATOR

Particiants in this group will receive a peri-articular injection of suspension (48 ml of 0.8% ropivacaine with 2 ml of 40mg methylprednisolone) combined with intravenous patient controlled analgesia post-operatively (tramadol 800 mg and flurbiprofenaxetil 100 mg with saline added up to a volume of 80 ml )

Procedure: LWI group

Interventions

CFNB group PROCEDURE

CFNB :A single injection of ropivacaine 30ml for femoral nerve block pre-operatively +0.15% ropivacaine 300ml for continuous femoral nerve block post-operatively guided by ultrasound and nerve stimulator.

CFNB group

LWI group PROCEDURE

LWI: 48 ml of 0.8% ropivacaine with 2 ml of 40mg methylprednisolone for intra-articular and peri-articular wound infiltration intra-operatively in combination with intravenous patient controlled analgesia post-operatively.

LWI group

Eligibility Criteria

• Age: 18 Years - 75 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 75 years old who had received 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
• local infection of puncture sites
• neurological diseases
• uncontrolled general infection
• intra-operative cardiac arrest.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (14)

• Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.

  PMID: 19546411 BACKGROUND

• 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.

  PMID: 9661552 BACKGROUND

• 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.

  PMID: 22503334 BACKGROUND

• Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.

  PMID: 11915059 BACKGROUND

• Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.

  PMID: 20966667 BACKGROUND

• Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14.

  PMID: 20551021 BACKGROUND

• Ilfeld BM, Mariano ER, Girard PJ, Loland VJ, Meyer SR, Donovan JF, Pugh GA, Le LT, Sessler DI, Shuster JJ, Theriaque DW, Ball ST. A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards. Pain. 2010 Sep;150(3):477-484. doi: 10.1016/j.pain.2010.05.028. Epub 2010 Jun 22.

  PMID: 20573448 BACKGROUND

• Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

  PMID: 18627367 BACKGROUND

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 BACKGROUND

• Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.

  PMID: 16651569 BACKGROUND

• Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.

  PMID: 20571832 BACKGROUND

• Koh IJ, Kang YG, Chang CB, Do SH, Seong SC, Kim TK. Does periarticular injection have additional pain relieving effects during contemporary multimodal pain control protocols for TKA?: A randomised, controlled study. Knee. 2012 Aug;19(4):253-9. doi: 10.1016/j.knee.2011.03.007. Epub 2011 Apr 19.

  PMID: 21507661 BACKGROUND

• Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.

  PMID: 15534532 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Min Su, MD.

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihua Peng, MD

CONTACT

+86-23-89011061; plhbest@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Department of Anesthesia and Pain Medicine

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2017
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CN (1)