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Completed

NCT Number: NCT04086186

Adductor Canal Block Versus Liposomal Bupivacaine in TKA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Good Samaritan Regional Medical Center

Corvallis, Oregon, 97330, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Liposomal Bupivacaine Peri-articular Injection

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.

Other names: Exparel peri-articular injection

Adductor canal block

Procedure

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

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: VAS pain score on post-operative day #1

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

  2. Visual Analog Scale (VAS)

    Time frame: VAS pain score on post-operative day #2

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

  3. Visual Analog Scale (VAS)

    Time frame: VAS pain score on post-operative day #4

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

  4. Visual Analog Scale (VAS)

    Time frame: VAS pain score on post-operative day #7

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

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Outcome measure will be assessed up to 8 weeks

    Reported WOMAC Score ranges between 0 (worst) to 100 (best)

  2. Knee range of motion

    Time frame: Outcome measure will be assessed up to 8 weeks

    Knee flexion and extension will be recorded during follow up visits

  3. Ambulation distance after surgery

    Time frame: Recorded on post-operative day #1

    Distance walked in feet will be assessed and recorded by physical therapist

  4. Hospital length of stay

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

    Measured by number of nights patient stayed in hospital after surgery

Sponsors and collaborators

Lead sponsor

Good Samaritan Regional Medical Center, Oregon

Other

Registry information

Official study title

Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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