Block and Periarticular Injection Study

NCT ID: NCT06410612

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-05-12

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

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Block and Periarticular injection

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

Group Type: ACTIVE_COMPARATOR

regional anesthesia and PAI

Intervention Type: DRUG

this is the block portion of the study

PAI

Intervention Type: DRUG

this is the no block portion of the study

Periarticular injectin alone

Periarticular injection alone

Group Type: ACTIVE_COMPARATOR

PAI

Intervention Type: DRUG

this is the no block portion of the study

Interventions

regional anesthesia and PAI

this is the block portion of the study

Intervention Type: DRUG

PAI

this is the no block portion of the study

Intervention Type: DRUG

Other Intervention Names

adductor canal block; periarticular injection; Periarticular injections

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

Creve Coeur, Missouri, United States

Countries

United States

Other Identifiers

202311211

Identifier Type: -

Identifier Source: org_study_id