Clinical trial NCT04513145: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Total Knee Replacement
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Towson Orthopaedic Associates
First posted: 2020-08-14
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1
timeFrame: Approximately 24 hours following closure
Secondary outcomes:
measure: 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
timeFrame: Every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
measure: Timed Up & Go test
timeFrame: 24 hours following surgical closure
measure: Gait Assessment
timeFrame: 24 hours following surgical closure
measure: Range of Motion
timeFrame: 24 hours following surgical closure
measure: Range of Motion
timeFrame: 4-6 weeks
measure: Quadriceps Strength
timeFrame: 24 hours following surgical closure
measure: Patient Satisfaction with Pain
timeFrame: 4-6 week visit
measure: Pain Diary
timeFrame: 7 days following surgical closure
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, OrthoCarolina, P.A.
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Bryan D Springer, MD
role: PRINCIPAL_INVESTIGATOR
References: