Adductor Canal Block Versus Liposomal Bupivacaine in TKA

NCT ID: NCT04086186

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-22

Study Completion Date

2018-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Total knee arthroplasty(TKA) is an effective solution for end stage arthritis of the knee; however, post-surgical pain can be difficult to manage and the optimal peri-operative pain management strategy has not been established. This study serves to evaluate the clinical outcomes of liposomal bupivacaine PAI when compared to single shot adductor canal block using bupivacaine HCl in patients undergoing a TKA. The investigators hypothesized that peri-articular injection with liposomal bupivacaine would not be inferior to an adductor canal block using bupivacaine HCl. A total of 60 patients were recruited. Thirty patients were randomized to receive intraoperative liposomal bupivacaine periarticular injection, and another thirty patients randomized to receive a pre-operative adductor canal block using bupivacaine. Both groups otherwise received standard pain management strategies peri-operatively. The primary outcome of interest was post-operative pain, which was measured using the Visual Analog Scale (VAS). Secondary measures included changes in patient function which was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, post-operative ambulation distance, and hospital length of stay.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Arthroplasty Post-operative Pain Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adductor Canal Block Group

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

Group Type ACTIVE_COMPARATOR

Adductor canal block

Intervention Type PROCEDURE

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

Liposomal Bupivacaine Group

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

Group Type EXPERIMENTAL

Liposomal Bupivacaine Peri-articular Injection

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liposomal Bupivacaine Peri-articular Injection

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.

Intervention Type PROCEDURE

Adductor canal block

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exparel peri-articular injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.)
2. Adults undergoing bilateral primary total knee arthroplasties.
3. Women who are pregnant.
4. Women who are breastfeeding.
5. Inability to receive successful spinal anesthesia.
6. Allergy to amide anesthetics.
7. Inability to receive IV tranexamic acid.
8. Patients who are unable to speak English.
9. Patients who are less than 66kg.
10. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Good Samaritan Regional Medical Center, Oregon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Justin Than

Orthopedic Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Justin Than, DO

Role: PRINCIPAL_INVESTIGATOR

Samaritan Health Services

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Good Samaritan Regional Medical Center

Corvallis, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17403800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21561303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16651569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24815964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19214642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29628196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29656977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28326395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28816893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26897490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27113945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22285545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26883652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27326760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26618816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26731385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24938586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19916251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21697687 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB16-021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

US Guided GNB vs Saline Injection for TKA
NCT03316118 TERMINATED PHASE4
Adductor Canal Block
NCT04513145 ACTIVE_NOT_RECRUITING PHASE2/PHASE3