Clinical trial

Multimodal Periarticular Analgesic Injection With and Without Surgeon-Administered Adductor Canal Block During Total Knee Arthroplasty: A Randomized Controlled Trial

Name
9172
Description
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
Trial arms
Trial start
2020-10-09
Estimated PCD
2024-12-01
Trial end
2025-07-01
Phase
Early phase I
Treatment
Ropivacaine injection
Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.
Arms:
Treatment Group (Ropivacaine)
Saline Injection
Saline will be used as a placebo injection
Arms:
Control Group (Saline)
Total Knee Arthroplasty
All subjects participating in this study will undergo primary total knee arthroplasty
Arms:
Control Group (Saline), Treatment Group (Ropivacaine)
Size
130
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both the investigator and participant will be blinded to the injection administered perioperatively', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}
Updated at
2024-04-02

1 organization

2 products

2 indications

Indication
Osteoarthritis
Product
Saline