What is the mechanism of action of this treatment?

Regional anesthesia techniques such as the Erector Spinae Block (ESB) and Quadratus Lumborum Block (QLB) provide postoperative pain relief by targeting and blocking nerve signals in specific regions of the body. ESB involves injecting anesthetic near the erector spinae muscles, which helps block pain signals from the spine and surrounding areas. QLB, on the other hand, involves injecting anesthetic near the quadratus lumborum muscle, which can block pain signals from the lower back and abdominal region. These blocks are crucial for postoperative pain management as they can significantly reduce the need for systemic opioids, minimize side effects, and enhance patient recovery by providing targeted, effective pain relief.

What side effects are associated with this type of intervention?

Common side effects of regional anesthesia techniques like Erector Spinae Block (ESB) and Quadratus Lumborum Block (QLB) include local anesthetic systemic toxicity (LAST), which can lead to seizures and cardiac issues, infection at the injection site, bleeding, nerve damage, and transient numbness or weakness in the affected area. Patients may also experience temporary increases in pain or discomfort at the injection site.

What prior FDA approvals exist?

The FDA has approved various regional anesthesia techniques and related drugs for the treatment of postoperative pain. These include local anesthetics such as bupivacaine, ropivacaine, and lidocaine, which are commonly used in nerve blocks like the Erector Spinae Block (ESB) and Quadratus Lumborum Block (QLB). These blocks are designed to provide targeted pain relief by inhibiting nerve signals in specific regions of the body, thereby reducing the need for systemic opioids and minimizing their associated side effects. Additionally, continuous infusion techniques using catheters for prolonged analgesia have also been approved and are widely used in clinical practice.

What other types of research exist?

Promising novel alternatives to ESB and QLB for postoperative pain management include: <ol> <li>Continuous Lumbar Plexus Block (LPB): This technique has shown improved analgesia with fewer side effects compared to systemic opioids in hip arthroplasty patients.</li> <li></li> </ol> Adductor Canal Block (ACB): This block provides effective pain relief with less impact on quadriceps strength, making it a favorable option for knee surgeries. 3. Genicular Nerve Block: Used for knee osteoarthritis, this block targets specific nerves around the knee and has shown modest pain improvement in clinical trials. 4. Prolotherapy: Although traditionally used for chronic pain, prolotherapy is gaining interest for its potential in postoperative pain management by promoting tissue repair and reducing pain.

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Quadratus Lumborum vs Erector Spinae Blocks for Postoperative Hip Surgery Pain

Phase 4

Waitlist Available

Led By ROLAND BRUSSEAU, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

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

Must have

ASA I - III status, undergoing unilateral periacetabular osteotomy for treating primary diagnosis of developmental acetabular dysplasia in symptomatic young patients.

Ages 15 - 30 years

Must not have

Patients undergoing procedures including revision PAO, bilateral PAO, conversion to total hip arthroplasty.

Patients whom for any reason did not received a lumbar plexus catheter as part of the baseline regional anesthesia plan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pacu stay

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two types of nerve blocks, ESB and QLB, used with a lumbar plexus block to manage pain in young patients after hip surgery. The goal is to see if there is any difference in pain relief and opioid use between the two methods. Both blocks aim to reduce pain by numbing specific nerves, potentially lowering the need for opioids. Quadratus lumborum block (QLB) has been increasingly used for pain control following hip surgeries, showing effectiveness in reducing postoperative pain and opioid consumption.

Who is the study for?

This trial is for young individuals aged 15-30 with developmental acetabular dysplasia experiencing hip pain, who are undergoing unilateral hip surgery. They must be in good health (ASA I - III status) and not overweight (BMI ≤ 35). Those with blood clotting issues, severe neurodevelopmental delays, chronic pain syndromes, recent opioid use, or without parental/patient consent are excluded.

What is being tested?

The study tests the effectiveness of two types of nerve blocks—quadratus lumborum block (QLB) and erector spinae block (ESB)—when used alongside a continuous lumbar plexus block for post-surgery pain relief in hip PAO surgery. It aims to determine if there's a difference in pain control between these two methods.

What are the potential side effects?

Ropivacaine used in both QLB and ESB may cause side effects like low blood pressure, nausea, vomiting, backache or soreness at the injection site. Serious side effects are rare but can include seizures or heart problems.

Eligibility Criteria

Inclusion Criteria

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

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I am having surgery for hip dysplasia and my health is relatively good.

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I am between 15 and 30 years old.

Exclusion Criteria

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

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I am having surgery to correct my hip, including adjustments or hip replacement.

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I did not receive a lumbar plexus catheter as initially planned.

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I have a history of chronic pain.

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I have a known blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rescue analgesic consumption

Secondary study objectives

Adverse events

Mean pain scores

PACU Time

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Erector spinae supplemental blockExperimental Treatment2 Interventions

Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg.

Group II: Quadratus lumborum supplemental blockActive Control2 Interventions

Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

0 / 6Eligibility 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

Regional anesthesia techniques such as the Erector Spinae Block (ESB) and Quadratus Lumborum Block (QLB) provide postoperative pain relief by targeting and blocking nerve signals in specific regions of the body. ESB involves injecting anesthetic near the erector spinae muscles, which helps block pain signals from the spine and surrounding areas. QLB, on the other hand, involves injecting anesthetic near the quadratus lumborum muscle, which can block pain signals from the lower back and abdominal region. These blocks are crucial for postoperative pain management as they can significantly reduce the need for systemic opioids, minimize side effects, and enhance patient recovery by providing targeted, effective pain relief.