Adductor Canal Block

Phase 2

• Conditions: Total Knee Replacement; Osteoarthritis
• Interventions: Drug: Saline Injection; Drug: Ropivacaine injection; Procedure: Total Knee Arthroplasty

• Registration Number: NCT04513145
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2020-10-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group (Ropivacaine)	Total Knee Arthroplasty	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.
Control Group (Saline)	Saline Injection	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.
Control Group (Saline)	Total Knee Arthroplasty	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 Group (Ropivacaine)	Ropivacaine injection	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.

Primary Outcome Measures

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

Name	Time	Method
Pain Diary	7 days following surgical closure	Patient-reported opioid consumption in morphine milliequivalents in first 7 days postoperatively as recorded in a pain diary
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	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.
Timed Up & Go test	24 hours following surgical closure	Timed up \& go test administered on postoperative day 1 by physical therapy
Gait Assessment	24 hours following surgical closure	Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1
Range of Motion	4-6 weeks	Range of motion in knee flexion and extension at 4-6 week visit administered by treating surgeon
Quadriceps Strength	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.
Patient Satisfaction with Pain	4-6 week visit	Patient-reported satisfaction with pain control on a 10-point Likert scale where 10 is the highest satisfaction

Trial Locations

Locations (1)

OrthoCarolina Research Institute, OrthoCarolina, P.A.; 🇺🇸 Charlotte, North Carolina, United States