Block and Periarticular Injection Study

The Washington University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: regional anesthesia and PAI; Drug: PAI

Study type: Interventional

Funder types: Other

Identifiers

NCT06410612

202311211

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Block and Periarticular injection

Active Comparator group

Description:

regional anesthesia (Adductor canal block +IPACK) and Periarticular injection

Treatment:

Drug: PAI

Drug: regional anesthesia and PAI

Periarticular injectin alone

Active Comparator group

Description:

Periarticular injection alone

Treatment:

Drug: PAI