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Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Primary Purpose

Total Knee Arthroplasty, Post-operative Pain Control

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Liposomal Bupivacaine Peri-articular Injection

Adductor canal block

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Good Samaritan Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adductor Canal Block Group

Liposomal Bupivacaine Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)

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

Visual Analog Scale (VAS)

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

Visual Analog Scale (VAS)

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

Visual Analog Scale (VAS)

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

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

Knee range of motion

Knee flexion and extension will be recorded during follow up visits

Ambulation distance after surgery

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

Hospital length of stay

Measured by number of nights patient stayed in hospital after surgery

Full Information

NCT ID

NCT04086186

First Posted

March 13, 2019

Last Updated

September 9, 2019

Sponsor

Good Samaritan Regional Medical Center, Oregon

1. Study Identification

Unique Protocol Identification Number

NCT04086186

Brief Title

Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 22, 2017 (Actual)

Primary Completion Date

November 25, 2018 (Actual)

Study Completion Date

December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Good Samaritan Regional Medical Center, Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Knee Arthroplasty, Post-operative Pain Control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adductor Canal Block Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Liposomal Bupivacaine Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Liposomal Bupivacaine Peri-articular Injection

Other Intervention Name(s)

Exparel peri-articular injection

Intervention Description

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

Intervention Name(s)

Adductor canal block

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

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

Time Frame

VAS pain score on post-operative day #1

Title

Visual Analog Scale (VAS)

Description

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

Time Frame

VAS pain score on post-operative day #2

Title

Visual Analog Scale (VAS)

Description

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

Time Frame

VAS pain score on post-operative day #4

Title

Visual Analog Scale (VAS)

Description

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

Time Frame

VAS pain score on post-operative day #7

Secondary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

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

Time Frame

Outcome measure will be assessed up to 8 weeks

Title

Knee range of motion

Description

Knee flexion and extension will be recorded during follow up visits

Time Frame

Outcome measure will be assessed up to 8 weeks

Title

Ambulation distance after surgery

Description

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

Time Frame

Recorded on post-operative day #1

Title

Hospital length of stay

Description

Measured by number of nights patient stayed in hospital after surgery

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justin Than, DO

Organizational Affiliation

Samaritan Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Good Samaritan Regional Medical Center

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Individual participant data to be available up to 7 years.

Citations:

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Citation

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Adductor Canal Block Versus Liposomal Bupivacaine in TKA

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