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Nerve Block for Knee Surgery Pain Control

Phase 2 & 3

Waitlist Available

Led By Bryan D Springer, MD

Research Sponsored by OrthoCarolina Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients with inflammatory arthritis

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit

Summary

This trial will help determine if a nerve block in addition to a cocktail of pain medications can help control pain better for patients undergoing knee surgery.

Who is the study for?

This trial is for individuals aged 30-85 who are having their first total knee replacement due to osteoarthritis and will stay in the hospital overnight. It's not for those who have taken opioids before surgery, need a revision or bilateral knee replacement, have post-traumatic or inflammatory arthritis, previous surgeries on that knee, same-day discharge plans, contralateral knee replacements, or a history of substance abuse.

What is being tested?

The study is testing if adding an adductor canal block with ropivacaine (a numbing medication) to standard pain relief methods provides better pain control after knee replacement surgery than using saline (a placebo). Patients receive either the real drug or saline alongside regular pain management.

What are the potential side effects?

Ropivacaine can cause side effects like nausea, vomiting, low blood pressure, dizziness, headaches and in rare cases nerve damage. Saline injections typically don't cause side effects but may include discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30-85 years old and having my first knee replacement due to arthritis, staying in the hospital overnight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inflammatory arthritis.

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I am having knee replacement surgery and will go home the same day.

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I have had surgery that opened my knee joint before.

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I am having surgery to replace both of my knees.

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I am having knee replacement surgery due to arthritis from an injury.

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I am having a second surgery to replace my knee joint.

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I have had knee replacement surgery on my other knee.

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I have been taking opioids before my knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1

Secondary study objectives

Gait Assessment

Pain

Patient Satisfaction with Pain

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group (Ropivacaine)Experimental Treatment2 Interventions

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.

Group II: Control Group (Saline)Placebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total Knee Arthroplasty

2017

Completed Phase 4

~1940

Ropivacaine injection

2012

Completed Phase 4

~510