Nerve Block for Postoperative Pain After ACL Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rothman Institute Orthopaedics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK. The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.

Research Team

Eligibility Criteria

This trial is for patients undergoing their first ACL reconstruction due to a tear, including those with additional meniscus surgery. It's not for people under 18, those having revision surgery, on worker's compensation, or pregnant women.

Inclusion Criteria

I am having ACL reconstruction, with or without meniscus surgery.

Exclusion Criteria

I am getting or have had a second ACL surgery.

I am under 18 years old.

Worker's compensation

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Treatment Details

Interventions

Adductor Canal Block (ACB) (Local Anesthetic)
Infiltration between Popliteal Artery and Capsule of the knee (iPACK) (Local Anesthetic)

Trial OverviewThe study tests pain management techniques after ACL surgery. It compares the effectiveness of an adductor canal block (ACB) alone versus ACB combined with iPACK in reducing pain and opioid use post-surgery.

Participant Groups

2Treatment groups

Active Control

Group I: isolated adductor canal block (ACB)Active Control3 Interventions

Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.

Group II: isolated adductor canal block (ACB) + IPACKActive Control4 Interventions

ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.