Adductor Canal Block

NCT04513145 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 9172
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (8)

• 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

• Timed Up & Go test

  24 hours following surgical closure

• Gait Assessment

  24 hours following surgical closure

• Range of Motion

  24 hours following surgical closure

• Range of Motion

  4-6 weeks

Study Arms (2)

Treatment Group (Ropivacaine)

EXPERIMENTAL

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.

Drug: Ropivacaine injection; Procedure: Total Knee Arthroplasty

Control Group (Saline)

PLACEBO COMPARATOR

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.

Drug: Saline Injection; Procedure: Total Knee Arthroplasty

Interventions

Ropivacaine injection DRUG

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

Treatment Group (Ropivacaine)

Saline Injection DRUG

Saline will be used as a placebo injection

Control Group (Saline)

Total Knee Arthroplasty PROCEDURE

All subjects participating in this study will undergo primary total knee arthroplasty

Control Group (Saline); Treatment Group (Ropivacaine)

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• Towson Orthopaedic Associates: collaborator

Study Sites (1)

OrthoCarolina Research Institute, OrthoCarolina, P.A.

Charlotte, North Carolina, 28209, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ropivacaine; Sodium Chloride; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Bryan D Springer, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the investigator and participant will be blinded to the injection administered perioperatively
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: October 9, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)