Regional Anesthesia vs Injection for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington University School of Medicine

Must not be taking: Opioids, Gabapentin, Pregabalin

Disqualifiers: BMI > 45, Neurologic disorders, Hepatic or renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andrew Schneider, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals undergoing knee replacement surgery who need pain management post-operation. Participants should be suitable for regional anesthesia and have no conditions that would interfere with the study.

Inclusion Criteria

Willing to sign informed consent

Willing to return for all follow-up visits

Having a smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria

Preexisting functionally limiting neurologic disorders

I regularly use opioids, gabapentin, or pregabalin more than 5 days a week.

I am scheduled for surgery under general anesthesia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either regional anesthesia (ACB + IPACK) and periarticular injection or periarticular injection alone

1 day

1 visit (in-person, day of surgery)

Postoperative Monitoring

Participants are monitored for pain relief and functional outcomes using VAS pain scores, step count, and other measures

2 weeks

Daily monitoring (virtual via app and Fitbit)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Adductor Canal Block plus IPACK Block
• Periarticular Injection

Trial Overview The study compares two pain relief methods after knee surgery: one group receives a nerve block plus an injection around the knee, while the other gets just the injection. The goal is to see which method better reduces pain and improves early movement.

Participant Groups

Group I: Block and Periarticular injection Active Control 2 Interventions

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

Group II: Periarticular injectin alone Active Control 1 Intervention

Periarticular injection alone

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+