Adductor Canal Block
Multimodal Periarticular Analgesic Injection With and Without Surgeon-Administered Adductor Canal Block During Total Knee Arthroplasty: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28209
- OrthoCarolina Research Institute, OrthoCarolina, P.A.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Patients undergoing revision total knee arthroplasty
- Patients undergoing bilateral total knee arthroplasty
- Workers compensation patients
- Patients undergoing total knee arthroplasty for post-traumatic arthritis
- Patients with inflammatory arthritis
- Patients with any previous surgery on the operative knee which involved an arthrotomy
- Patients taking opioids prior to total knee arthroplasty
- Patients with a known history of drug or alcohol abuse
- 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)
- Patients who have had a total knee arthroplasty performed on the contralateral knee
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.
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.
|
All subjects participating in this study will undergo primary total knee arthroplasty
Saline will be used as a placebo injection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Approximately 24 hours following closure
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
Every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
|
|
Timed Up & Go test
Time Frame: 24 hours following surgical closure
|
Timed up & go test administered on postoperative day 1 by physical therapy
|
24 hours following surgical closure
|
|
Gait Assessment
Time Frame: 24 hours following surgical closure
|
Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1
|
24 hours following surgical closure
|
|
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
|
24 hours following surgical closure
|
|
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
|
4-6 weeks
|
|
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.
|
24 hours following surgical closure
|
|
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
|
4-6 week visit
|
|
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
|
7 days following surgical closure
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Bryan D Springer, MD, OrthoCarolina Research Institute, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Organic Chemicals
- Surgical Procedures, Operative
- Anilides
- Amides
- Aniline Compounds
- Amines
- Inorganic Chemicals
- Chlorine Compounds
- Arthroplasty, Replacement
- Arthroplasty
- Orthopedic Procedures
- Plastic Surgery Procedures
- Prosthesis Implantation
- Sodium Compounds
- Chlorides
- Hydrochloric Acid
- Ropivacaine
- Arthroplasty, Replacement, Knee
- Sodium Chloride
Other Study ID Numbers
Other Study ID Numbers
- 9172 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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