Clinical trial NCT06410612: Block and Periarticular Injection Study
Official title: The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized into 2 groups.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively
timeFrame: at 2 weeks
Secondary outcomes:
measure: daily opioid consumption
timeFrame: daily up to 2 weeks postop
measure: daily resting Visual Analog Scale (VAS) score
timeFrame: daily up to 2 weeks postop
measure: daily step count
timeFrame: daily up to 2 weeks postop
measure: length of stay
timeFrame: postop day 1
measure: complications
timeFrame: 14 days postop
measure: knee range of motion
timeFrame: daily through app and knee brace up to 2 weeks postop
measure: Oxford knee score
timeFrame: weekly up to 2 weeks postop
measure: sleep quality
timeFrame: daily up to 2 weeks postop
Other outcomes:
Locations:
city: Creve Coeur
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Andrew Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: