What side effects are associated with this type of intervention?

Common treatments for pain management similar to the Erector Spinae Plane (ESP) Block, which involves the use of local anesthetics, include local anesthetic injections and nerve blocks. Known side effects of these treatments can include local pain at the injection site, transient numbness, paraesthesias (abnormal sensations), and in some cases, superficial burns. Additionally, there may be risks of increased pain and transient lower limb numbness. These side effects are generally mild and temporary but should be monitored by healthcare professionals.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management that are similar to the Erector Spinae Plane (ESP) Block, which involves the spread of local anesthetic into the paravertebral space for truncal analgesia. Notably, transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS) are approved neuromodulation techniques for chronic pain management. Additionally, local anesthetics like lidocaine and bupivacaine are commonly used in nerve blocks for regional anesthesia. These treatments aim to provide effective pain relief by targeting specific nerves or regions, similar to the mechanism of the ESP block.

What other types of research exist?

Promising alternatives to the Erector Spinae Plane (ESP) Block for truncal analgesia include: 1) Genicular nerve block, which has shown efficacy in knee osteoarthritis pain management and may be adapted for other pain conditions. 2) Sphenopalatine ganglion block, which has been effective in headache and migraine management and could be explored for truncal pain. 3) Percutaneous electrical nerve stimulation (PENS), which has shown moderate to substantial pain relief in chronic low back pain and could be adapted for truncal analgesia. These alternatives offer different mechanisms of action and may provide effective pain relief for patients seeking novel treatments.

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IV Lidocaine vs. ESP Block for Postoperative Pain

Phase 2

Waitlist Available

Led By Archit Sharma, MD

Research Sponsored by Archit Sharma

Eligibility Criteria Checklist

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

Must have

Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy

Be older than 18 years old

Must not have

Emergency surgery

Major liver or kidney dysfunction or other pre-existing major organ dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours post surgical intervention

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial investigates a pain relief method for patients after open heart surgery. It involves an injection near the spine to numb the chest and back area by blocking pain signals. This approach aims to manage significant post-operative pain effectively.

Who is the study for?

This trial is for English-speaking adults scheduled for elective cardiac surgery through sternotomy, specifically CABG or valve surgery. It's not suitable for those unable to consent, prisoners, emergency cases, with psychiatric issues affecting consent, pregnant women, those with certain medical conditions like severe organ dysfunction or coagulation disorders, a BMI outside of 20-35 range, drug dependencies or chronic pain.

What is being tested?

The study is testing two methods of pain management after heart surgery: one group receives Lidocaine intravenously (IV), while the other gets it via an Erector Spinae Plane (ESP) catheter. The ESP block aims to reduce trunk pain by targeting the paravertebral space but its effectiveness in doing so has been questioned.

What are the potential side effects?

Potential side effects from Lidocaine may include allergic reactions if sensitive to the medication; symptoms can range from minor skin irritations to more serious effects on heart rhythm and nervous system functions.

Eligibility Criteria

Inclusion Criteria

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

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You are scheduled to have heart surgery for blocked arteries or valve problems.

Exclusion Criteria

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

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You have a serious problem with your liver, kidneys, or other major organs.

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You have had heart surgery done again.

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You have had chest surgery through a large incision in the chest.

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You have had a heart surgery without the use of a heart-lung machine.

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You have long-lasting pain, like fibromyalgia.

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You have a serious brain or lung disease.

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You have blood disorders or abnormal blood clotting tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours post surgical intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours post surgical intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post surgical intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Compare Pain Score Reported by Subject 24 Hours Postoperatively

Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours

Secondary study objectives

Compare Pain Score Reported by Subject 48 Hours Postoperatively

Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention

Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Erector Spinae Plane Block-Administration of LidocaineExperimental Treatment1 Intervention

Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.

Group II: Intravenous-Administration of LidocaineActive Control1 Intervention

Sham block procedure (catheter will be taped to subjects skin). Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours after sham catheter placement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

FDA approved

0 / 10Eligibility 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 Erector Spinae Plane (ESP) Block provides pain relief by administering local anesthetics that spread into the paravertebral space, targeting the nerves responsible for transmitting pain signals from the trunk. This mechanism is crucial for pain management as it offers targeted, regional analgesia, reducing the need for systemic medications and their associated side effects. Similar treatments, such as nerve blocks and epidural injections, also work by delivering anesthetics or steroids directly to the vicinity of the affected nerves, thereby interrupting pain transmission and providing significant relief for patients with localized pain conditions.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.