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Adductor Canal Block

Primary Purpose

Osteoarthritis, Total Knee Replacement

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine injection
Saline Injection
Total Knee Arthroplasty
Sponsored by
OrthoCarolina Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Patients age 30-85undergoing first-time primary unilateral total knee arthroplasty for osteoarthritis and remaining hospitalized for at least one night

Exclusion Criteria:

  1. Patients undergoing revision total knee arthroplasty
  2. Patients undergoing bilateral total knee arthroplasty
  3. Workers compensation patients
  4. Patients undergoing total knee arthroplasty for post-traumatic arthritis
  5. Patients with inflammatory arthritis
  6. Patients with any previous surgery on the operative knee which involved an arthrotomy
  7. Patients taking opioids prior to total knee arthroplasty
  8. Patients with a known history of drug or alcohol abuse
  9. Patients undergoing total knee arthroplasty at an ambulatory surgery center, or being discharged home from the hospital on the same day as their procedure (planned)
  10. Patients who have had a total knee arthroplasty performed on the contralateral knee

Sites / Locations

  • OrthoCarolina Research Institute, OrthoCarolina, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group (Ropivacaine)

Control Group (Saline)

Arm Description

The treatment group will consist of patients undergoing total knee arthroplasty who receive standardized 100 cc periarticularinjection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients will then receive 10cc of ropivacaineinto their adductor canal.This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.

The control group will consist of patients undergoing total knee arthroplasty who receive a standardized periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients randomized in this group will then receive 10cc of saline into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.

Outcomes

Primary Outcome Measures

Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1
Pain will be measured before discharge on postoperative day 1 on a scale of 0 (no pain) - 10 (worst pain)

Secondary Outcome Measures

Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 0, 1, 2, 4 and at 4-6 week postoperative visit
Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0 (no pain) - 10 (worst pain) on: Postoperative day 0: in PACU and Q 6 hours Postoperative day 1: Q 6 hours Postoperative day 2: Q 6 hours via pain diary Postoperative day 4: Q 6 hours via pain diary 4-6 weeks postoperatively in office visit.
Timed Up & Go test
Timed up & go test administered on postoperative day 1 by physical therapy
Gait Assessment
Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1
Range of Motion
Range of motion in knee flexion and extension on postoperative day 1 administered by physical therapy
Range of Motion
Range of motion in knee flexion and extension at 4-6 week visit administered by treating surgeon
Quadriceps Strength
Quadriceps Strength (motor blockade) as demonstrated by ability to have active extension and perform a straight leg raise at Physical Therapy on postoperative day # 0 and postoperative day #1 prior to discharge.
Patient Satisfaction with Pain
Patient-reported satisfaction with pain control on a 10-point Likert scale where 10 is the highest satisfaction
Pain Diary
Patient-reported opioid consumption in morphine milliequivalents in first 7 days postoperatively as recorded in a pain diary

Full Information

First Posted
August 11, 2020
Last Updated
June 30, 2023
Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Towson Orthopaedic Associates
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1. Study Identification

Unique Protocol Identification Number
NCT04513145
Brief Title
Adductor Canal Block
Official Title
Multimodal Periarticular Analgesic Injection With and Without Surgeon-Administered Adductor Canal Block During Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Towson Orthopaedic Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators aim to investigate whether the addition of a surgeon-administered adductor canal blockade to a multimodal periarticular injection cocktail provides additional pain relief for patients undergoing total knee arthroplasty. This study will help identify the effectiveness of surgeon-administered adductor canal blockade in perioperative pain control for patients undergoing total knee arthroplasty
Detailed Description
Local anesthesia is an important component of multimodal pain management during the perioperative period for total knee arthroplasty, particularly with increased emphasis on early mobilization and decreased length of stay. Periarticular injections and regional nerve blocks are both effective in providing short-term pain relief when administered in isolation, and multiple randomized controlled trials have demonstrated that when administered in conjunction with one another, they also provide a synergistic effect. Periarticular injections are the simplest mechanism for infiltrating the surgical site with analgesic medications, and these provide effective pain relief. One described technique involves infiltrating this mixture into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin during various portions of a total knee arthroplasty. This is the technique used in our practice. Regional nerve blocks also have beneficial effects on pain, early mobilization and length of stay. Traditionally, anesthesiologist-administered femoral nerve blocks were utilized for this purpose. The femoral nerve consists of 4 main branches:the terminal portion of the vastusmedialis branch innervates the medial collateral ligament (MCL). The terminal portion of the vastusintermedius branch innervates the anterosuperior aspect of the knee capsule. The terminal portion of the vastuslateralis branch does not innervate the knee capsule. The saphenous nerve is the terminal sensory branch of the femoral nerve and travels in the adductor canal. It gives off an infrapatellar branch which exits the adductor canal to innervate the skin on the anteromedial aspect of the knee and the anteroinferior aspect of the knee capsule. Blockade of the entire femoral nerve results in significant quadriceps motor deficits. Adductor canal blocks can be targeted to anesthetize only the saphenous branch of the femoral nerve, however, and this spares the motor innervation to the quadriceps. Multiple randomized controlled trials have shown that these adductor canal blockades provide equivalent analgesic effects to femoral nerve blocks without associated deficits in quadriceps strength. In one study, quadriceps strength was measured immediately prior to and immediately following placement of femoral and adductor can blocks in patients undergoing TKA. After the femoral block, quadriceps strength decreased to 16% of the baseline pre-block value. After the adductor-canal-block, however, strength increased to 193% of the pre-block value. MRI measurements, cadaveric injections, and dissections have shown that a surgeon-performed injection of the saphenous nerve from within the knee after it exits from the adductor canal is a feasible procedure, and a randomized controlled trial found that a surgeon-administered adductor canal blockade was non-inferior to the traditional adductor canal blockade administered by an anesthesiologist. This technique is simple and can be easily performed during administration of a periarticular injection. It is unclear based on the current literature whether this surgeon-administered adductor canal blockade provides a synergistic effect on pain relief when combined with a periarticular injection. Treatment Group: The treatment group will consist of patients undergoing total knee arthroplasty who receive standardized 100 cc periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients will then receive 10cc of ropivacaine into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance. Comparison (Control) Group: The control group will consist of patients undergoing total knee arthroplasty who receive a standardized periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients randomized in this group will then receive 10cc of saline into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Both the investigator and participant will be blinded to the injection administered perioperatively
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group (Ropivacaine)
Arm Type
Experimental
Arm Description
The treatment group will consist of patients undergoing total knee arthroplasty who receive standardized 100 cc periarticularinjection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients will then receive 10cc of ropivacaineinto their adductor canal.This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.
Arm Title
Control Group (Saline)
Arm Type
Placebo Comparator
Arm Description
The control group will consist of patients undergoing total knee arthroplasty who receive a standardized periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients randomized in this group will then receive 10cc of saline into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.
Intervention Type
Drug
Intervention Name(s)
Saline Injection
Intervention Description
Saline will be used as a placebo injection
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty
Intervention Description
All subjects participating in this study will undergo primary total knee arthroplasty
Primary Outcome Measure Information:
Title
Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1
Description
Pain will be measured before discharge on postoperative day 1 on a scale of 0 (no pain) - 10 (worst pain)
Time Frame
Approximately 24 hours following closure
Secondary Outcome Measure Information:
Title
Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 0, 1, 2, 4 and at 4-6 week postoperative visit
Description
Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0 (no pain) - 10 (worst pain) on: Postoperative day 0: in PACU and Q 6 hours Postoperative day 1: Q 6 hours Postoperative day 2: Q 6 hours via pain diary Postoperative day 4: Q 6 hours via pain diary 4-6 weeks postoperatively in office visit.
Time Frame
Every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
Title
Timed Up & Go test
Description
Timed up & go test administered on postoperative day 1 by physical therapy
Time Frame
24 hours following surgical closure
Title
Gait Assessment
Description
Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1
Time Frame
24 hours following surgical closure
Title
Range of Motion
Description
Range of motion in knee flexion and extension on postoperative day 1 administered by physical therapy
Time Frame
24 hours following surgical closure
Title
Range of Motion
Description
Range of motion in knee flexion and extension at 4-6 week visit administered by treating surgeon
Time Frame
4-6 weeks
Title
Quadriceps Strength
Description
Quadriceps Strength (motor blockade) as demonstrated by ability to have active extension and perform a straight leg raise at Physical Therapy on postoperative day # 0 and postoperative day #1 prior to discharge.
Time Frame
24 hours following surgical closure
Title
Patient Satisfaction with Pain
Description
Patient-reported satisfaction with pain control on a 10-point Likert scale where 10 is the highest satisfaction
Time Frame
4-6 week visit
Title
Pain Diary
Description
Patient-reported opioid consumption in morphine milliequivalents in first 7 days postoperatively as recorded in a pain diary
Time Frame
7 days following surgical closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Patients age 30-85undergoing first-time primary unilateral total knee arthroplasty for osteoarthritis and remaining hospitalized for at least one night Exclusion Criteria: Patients undergoing revision total knee arthroplasty Patients undergoing bilateral total knee arthroplasty Workers compensation patients Patients undergoing total knee arthroplasty for post-traumatic arthritis Patients with inflammatory arthritis Patients with any previous surgery on the operative knee which involved an arthrotomy Patients taking opioids prior to total knee arthroplasty Patients with a known history of drug or alcohol abuse Patients undergoing total knee arthroplasty at an ambulatory surgery center, or being discharged home from the hospital on the same day as their procedure (planned) Patients who have had a total knee arthroplasty performed on the contralateral knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan D Springer, MD
Organizational Affiliation
OrthoCarolina Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina Research Institute, OrthoCarolina, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to currently make individual participant data available to other researchers

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Adductor Canal Block

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