NCT04086186

Brief Summary

This is a randomized prospective study of 60 patients undergoing total knee arthroplasty evaluating the clinical outcomes of liposomal bupivacaine periarticular injections (PAI) when compared to single shot adductor canal block using bupivacaine HCl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

March 13, 2019

Last Update Submit

September 9, 2019

Conditions

Total Knee ArthroplastyPost-operative Pain Control

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS)

    Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

    VAS pain score on post-operative day #1

  • Visual Analog Scale (VAS)

    Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

    VAS pain score on post-operative day #2

  • Visual Analog Scale (VAS)

    Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

    VAS pain score on post-operative day #4

  • Visual Analog Scale (VAS)

    Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

    VAS pain score on post-operative day #7

Secondary Outcomes (4)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Outcome measure will be assessed up to 8 weeks

  • Knee range of motion

    Outcome measure will be assessed up to 8 weeks

  • Ambulation distance after surgery

    Recorded on post-operative day #1

  • Hospital length of stay

    Measure outcome will be assess through study completion, on average of 1 year

Study Arms (2)

Adductor Canal Block Group

ACTIVE COMPARATOR

Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery.

Procedure: Adductor canal block

Liposomal Bupivacaine Group

EXPERIMENTAL

Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery.

Procedure: Liposomal Bupivacaine Peri-articular Injection

Interventions

Liposomal Bupivacaine Peri-articular InjectionPROCEDURE

A 20mL solution of 266mg of liposomal bupivacaine (Exparel) was mixed with 40mL of normal saline, which was then infiltrated consistently in the posterior capsule, medial and lateral side of the arthrotomy, patella tendon, quadriceps tendon, quadriceps musculature, and subcutaneous soft tissue.

Also known as: Exparel peri-articular injection
Liposomal Bupivacaine Group
Adductor canal blockPROCEDURE

Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl

Adductor Canal Block Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing unilateral primary total knee arthroplasty for end stage osteoarthritis or rheumatoid arthritis.
  • All adults \> 18 years of age.

You may not qualify if:

  • Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.)
  • Adults undergoing bilateral primary total knee arthroplasties.
  • Women who are pregnant.
  • Women who are breastfeeding.
  • Inability to receive successful spinal anesthesia.
  • Allergy to amide anesthetics.
  • Inability to receive IV tranexamic acid.
  • Patients who are unable to speak English.
  • Patients who are less than 66kg.
  • Patients who are opioid dependent. We define opioid dependency as patients who are on a long-acting narcotic or patients who are taking more than six tablets of hydrocodone 5mg or equivalent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Regional Medical Center

Corvallis, Oregon, 97330, United States

Location

Related Publications (19)

  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PMID: 17403800BACKGROUND

  • Affas F, Nygards EB, Stiller CO, Wretenberg P, Olofsson C. Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block. Acta Orthop. 2011 Aug;82(4):441-7. doi: 10.3109/17453674.2011.581264. Epub 2011 May 11.

    PMID: 21561303BACKGROUND

  • 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: 16651569BACKGROUND

  • Tong YC, Kaye AD, Urman RD. Liposomal bupivacaine and clinical outcomes. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):15-27. doi: 10.1016/j.bpa.2014.02.001. Epub 2014 Mar 15.

    PMID: 24815964BACKGROUND

  • Maheshwari AV, Blum YC, Shekhar L, Ranawat AS, Ranawat CS. Multimodal pain management after total hip and knee arthroplasty at the Ranawat Orthopaedic Center. Clin Orthop Relat Res. 2009 Jun;467(6):1418-23. doi: 10.1007/s11999-009-0728-7. Epub 2009 Feb 13.

    PMID: 19214642BACKGROUND

  • Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12.

    PMID: 29628196BACKGROUND

  • Zlotnicki JP, Hamlin BR, Plakseychuk AY, Levison TJ, Rothenberger SD, Urish KL. Liposomal Bupivacaine vs Plain Bupivacaine in Periarticular Injection for Control of Pain and Early Motion in Total Knee Arthroplasty: A Randomized, Prospective Study. J Arthroplasty. 2018 Aug;33(8):2460-2464. doi: 10.1016/j.arth.2018.03.014. Epub 2018 Mar 16.

    PMID: 29656977BACKGROUND

  • Snyder MA, Scheuerman CM, Gregg JL, Ruhnke CJ, Eten K. Improving total knee arthroplasty perioperative pain management using a periarticular injection with bupivacaine liposomal suspension. Arthroplast Today. 2016 Jan 11;2(1):37-42. doi: 10.1016/j.artd.2015.05.005. eCollection 2016 Mar.

    PMID: 28326395BACKGROUND

  • Smith EB, Kazarian GS, Maltenfort MG, Lonner JH, Sharkey PF, Good RP. Periarticular Liposomal Bupivacaine Injection Versus Intra-Articular Bupivacaine Infusion Catheter for Analgesia After Total Knee Arthroplasty: A Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Aug 16;99(16):1337-1344. doi: 10.2106/JBJS.16.00571.

    PMID: 28816893BACKGROUND

  • Schwarzkopf R, Drexler M, Ma MW, Schultz VM, Le KT, Rutenberg TF, Rinehart JB. Is There a Benefit for Liposomal Bupivacaine Compared to a Traditional Periarticular Injection in Total Knee Arthroplasty Patients With a History of Chronic Opioid Use? J Arthroplasty. 2016 Aug;31(8):1702-5. doi: 10.1016/j.arth.2016.01.037. Epub 2016 Jan 30.

    PMID: 26897490BACKGROUND

  • Jain RK, Porat MD, Klingenstein GG, Reid JJ, Post RE, Schoifet SD. The AAHKS Clinical Research Award: Liposomal Bupivacaine and Periarticular Injection Are Not Superior to Single-Shot Intra-articular Injection for Pain Control in Total Knee Arthroplasty. J Arthroplasty. 2016 Sep;31(9 Suppl):22-5. doi: 10.1016/j.arth.2016.03.036. Epub 2016 Mar 26.

    PMID: 27113945BACKGROUND

  • Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

    PMID: 22285545BACKGROUND

  • Yu S, Szulc A, Walton S, Bosco J, Iorio R. Pain Control and Functional Milestones in Total Knee Arthroplasty: Liposomal Bupivacaine versus Femoral Nerve Block. Clin Orthop Relat Res. 2017 Jan;475(1):110-117. doi: 10.1007/s11999-016-4740-4.

    PMID: 26883652BACKGROUND

  • Kirkness CS, Asche CV, Ren J, Gordon K, Maurer P, Maurer B, Maurer BT. Assessment of liposome bupivacaine infiltration versus continuous femoral nerve block for postsurgical analgesia following total knee arthroplasty: a retrospective cohort study. Curr Med Res Opin. 2016 Oct;32(10):1727-1733. doi: 10.1080/03007995.2016.1205007. Epub 2016 Jul 18.

    PMID: 27326760BACKGROUND

  • Horn BJ, Cien A, Reeves NP, Pathak P, Taunt CJ Jr. Femoral Nerve Block vs Periarticular Bupivacaine Liposome Injection After Primary Total Knee Arthroplasty: Effect on Patient Outcomes. J Am Osteopath Assoc. 2015 Dec;115(12):714-9. doi: 10.7556/jaoa.2015.146.

    PMID: 26618816BACKGROUND

  • Cien AJ, Penny PC, Horn BJ, Popovich JM, Taunt CJ. Comparison Between Liposomal Bupivacaine and Femoral Nerve Block in Patients Undergoing Primary Total Knee Arthroplasty. J Surg Orthop Adv. 2015 Winter;24(4):225-9.

    PMID: 26731385BACKGROUND

  • Broome CB, Burnikel B. Novel strategies to improve early outcomes following total knee arthroplasty: a case control study of intra articular injection versus femoral nerve block. Int Orthop. 2014 Oct;38(10):2087-9. doi: 10.1007/s00264-014-2392-0. Epub 2014 Jun 18.

    PMID: 24938586BACKGROUND

  • Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

    PMID: 19916251BACKGROUND

  • Saranteas T, Anagnostis G, Paraskeuopoulos T, Koulalis D, Kokkalis Z, Nakou M, Anagnostopoulou S, Kostopanagiotou G. Anatomy and clinical implications of the ultrasound-guided subsartorial saphenous nerve block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):399-402. doi: 10.1097/AAP.0b013e318220f172.

    PMID: 21697687BACKGROUND

Study Officials

  • Justin Than, DO

    Samaritan Health Services

    PRINCIPAL INVESTIGATOR

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
Orthopedic Resident

Study Record Dates

First Submitted

March 13, 2019

First Posted

September 11, 2019

Study Start

March 22, 2017

Primary Completion

November 25, 2018

Study Completion

December 18, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Individual participant data to be available up to 7 years.

Locations

US(1)