What side effects are associated with this type of intervention?

Common side effects of nerve blocks used in the treatment of Anterior Cruciate Ligament (ACL) rupture include temporary numbness, weakness in the affected limb, and potential allergic reactions to the anesthetic. There is also a risk of infection at the injection site, bleeding, and, in rare cases, nerve damage. Systemic effects such as dizziness, tinnitus, or cardiovascular and central nervous system toxicity can occur if the anesthetic spreads beyond the targeted area.

What prior FDA approvals exist?

The FDA has approved various treatments for managing pain associated with Anterior Cruciate Ligament (ACL) rupture, including the use of local anesthetics for nerve blocks. These treatments aim to block nerve transmission to alleviate pain during and after surgical procedures. Commonly used local anesthetics include bupivacaine, ropivacaine, and mepivacaine, which have been studied for their efficacy and safety in pain management. While specific FDA approvals for nerve blocks in ACL rupture cases are not detailed, these anesthetics are widely used in clinical practice for similar purposes.

What other types of research exist?

Promising alternatives to nerve blocks for ACL rupture patients include local infiltration analgesia (LIA), which involves the direct injection of anesthetics and analgesics into the surgical site, and multimodal analgesia protocols that combine different types of pain relief methods to minimize opioid use. The use of gabapentin or pregabalin preoperatively has also shown efficacy in reducing postoperative pain. These methods offer effective pain control and may reduce the need for nerve blocks.

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Pain Management Techniques for ACL Surgery

N/A

Waitlist Available

Led By Cassandra Lee, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 and 45 years old

Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted

Must not have

Non-English-speaking patients

Inflammatory arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial compares pain control methods for ACL surgery patients, using either a nerve block or oral medications. It aims to see if both methods provide similar pain relief and recovery outcomes. The study will also assess the cost-effectiveness and patient flow logistics of each method.

Who is the study for?

This trial is for adults aged 18-45 who have confirmed ACL tears and are recommended to undergo reconstructive surgery. It's not suitable for those unable to consent, pregnant women, individuals with inflammatory arthritis, non-English speakers, anyone with prior knee surgeries, or prisoners.

What is being tested?

The study compares standard pain management techniques during ACL reconstruction surgery. Specifically, it looks at the effectiveness of an adductor canal nerve block using Ropivacaine injection versus no nerve block in controlling pain and improving functional outcomes post-surgery.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, numbness in the leg due to the nerve block, possible allergic reactions to Ropivacaine including itching or rash, and less commonly complications related to nerve blocks such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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My ACL tear is confirmed by tests and I need surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I have inflammatory arthritis.

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I am under 18 years old.

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I have not had surgery on either of my knees.

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immediate Post-op Pain Score

Opioid Use

Secondary study objectives

Intermediate-term Knee Function

Long-term Knee Function

Post-anaesthesia care unit (PACU) Time

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adductor Canal Nerve BlockExperimental Treatment2 Interventions

Participant will receive an adductor canal nerve block via 15 mL 0.5% ropivacaine injection prior to OR for ACL reconstruction. Participant will receive pre-op oral medications.

Group II: No Nerve BlockActive Control1 Intervention

Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine injection

2012

Completed Phase 4

~510

Adductor Canal Nerve Block

2016

Completed Phase 4

~210

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anterior Cruciate Ligament (ACL) rupture include surgical reconstruction, physical therapy, and nerve blocks. Surgical reconstruction involves replacing the torn ligament with a graft, which helps restore knee stability and function. Physical therapy focuses on strengthening the muscles around the knee and improving range of motion, which is crucial for recovery and preventing further injury. Nerve blocks, such as local anesthetic nerve blocks, work by temporarily blocking nerve transmission to reduce pain during and after surgery. This is particularly important for ACL rupture patients as it can significantly improve pain management, enhance postoperative recovery, and facilitate early mobilization, which is essential for successful rehabilitation.