Adductor Canal Block

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04513145
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

OrthoCarolina Research Institute, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bryan D Springer, MD
Principal Investigator Affiliation OrthoCarolina Research Institute, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Total Knee Replacement
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Drug: - Ropivacaine injection

Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Charlotte, North Carolina

Status

Address

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Charlotte, North Carolina, 28209