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Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT04513145
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Towson Orthopaedic Associates
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Total Knee Replacement Drug: Ropivacaine injection Drug: Saline Injection Procedure: Total Knee Arthroplasty Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Both the investigator and participant will be blinded to the injection administered perioperatively
Primary Purpose: Treatment
Official Title: Multimodal Periarticular Analgesic Injection With and Without Surgeon-Administered Adductor Canal Block During Total Knee Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Treatment Group (Ropivacaine)
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.
Drug: Ropivacaine injection
Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.

Procedure: Total Knee Arthroplasty
All subjects participating in this study will undergo primary total knee arthroplasty

Placebo Comparator: Control Group (Saline)
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.
Drug: Saline Injection
Saline will be used as a placebo injection

Procedure: Total Knee Arthroplasty
All subjects participating in this study will undergo primary total knee arthroplasty




Primary Outcome Measures :
  1. Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1 [ Time Frame: Approximately 24 hours following closure ]
    Pain will be measured before discharge on postoperative day 1 on a scale of 0 (no pain) - 10 (worst pain)


Secondary Outcome Measures :
  1. 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 [ Time Frame: Every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week 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.

  2. Timed Up & Go test [ Time Frame: 24 hours following surgical closure ]
    Timed up & go test administered on postoperative day 1 by physical therapy

  3. Gait Assessment [ Time Frame: 24 hours following surgical closure ]
    Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1

  4. Range of Motion [ Time Frame: 24 hours following surgical closure ]
    Range of motion in knee flexion and extension on postoperative day 1 administered by physical therapy

  5. Range of Motion [ Time Frame: 4-6 weeks ]
    Range of motion in knee flexion and extension at 4-6 week visit administered by treating surgeon

  6. Quadriceps Strength [ Time Frame: 24 hours following surgical closure ]
    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.

  7. Patient Satisfaction with Pain [ Time Frame: 4-6 week visit ]
    Patient-reported satisfaction with pain control on a 10-point Likert scale where 10 is the highest satisfaction

  8. Pain Diary [ Time Frame: 7 days following surgical closure ]
    Patient-reported opioid consumption in morphine milliequivalents in first 7 days postoperatively as recorded in a pain diary



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513145


Locations
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United States, North Carolina
OrthoCarolina Research Institute, OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28209
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Towson Orthopaedic Associates
Investigators
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Principal Investigator: Bryan D Springer, MD OrthoCarolina Research Institute, Inc.
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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04513145    
Other Study ID Numbers: 9172
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to currently make individual participant data available to other researchers

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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
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents