Block and Periarticular Injection Study
- Conditions
- Pain, Postoperative
- Interventions
- Drug: PAIDrug: regional anesthesia and PAI
- Registration Number
- NCT06410612
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.
- Detailed Description
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.
Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- Planning to undergo Unilateral primary total knee arthroplasty.
- 18 and up
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the FocusMotion platform
- BMI > 45
- Preexisting functionally limiting neurologic disorders
- Hepatic or renal insufficiency
- History of unprovoked venous thromboembolism
- Inability to complete baseline functional testing
- Chronic opioid or gabapentin and pregabalin use (chronic defined as use >5 days per week prior to the surgical procedure)
- Allergy or intolerance to trial medications
- Planned admission to a postoperative rehabilitation facility
- Planned general anesthesia
- Receiving workers compensation or disability payments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Periarticular injectin alone PAI Periarticular injection alone Block and Periarticular injection PAI regional anesthesia (Adductor canal block +IPACK) and Periarticular injection Block and Periarticular injection regional anesthesia and PAI regional anesthesia (Adductor canal block +IPACK) and Periarticular injection
- Primary Outcome Measures
Name Time Method Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively at 2 weeks pain score 0-10 10 being more pain
- Secondary Outcome Measures
Name Time Method daily resting Visual Analog Scale (VAS) score daily up to 2 weeks postop Pain score survey 0-10, 10 being more pain
knee range of motion daily through app and knee brace up to 2 weeks postop range of motion daily through app exercises
length of stay postop day 1 in hospital stay
daily opioid consumption daily up to 2 weeks postop opioid medications survey
daily step count daily up to 2 weeks postop step count throught fitbit
complications 14 days postop Number of participants with complications such as revision, infection, etc
sleep quality daily up to 2 weeks postop sleep quality through app surveys and fitbit data
Oxford knee score weekly up to 2 weeks postop oxford knee survey through app, 0-48 scale 0 being min and 48 being max
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Creve Coeur, Missouri, United States