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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 2 days post surgical intervention
Awards & highlights

Study Summary

This trial found that the erector spinae plane (ESP) block does not reliably provide truncal analgesia by spread of local anesthetic into the paravertebral space.

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.Check my eligibility
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.See study design
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
Select...
You are scheduled to have heart surgery for blocked arteries or valve problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 2 days post surgical intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 2 days post surgical intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantitate and report changes in pain scores reported by subject
Quantitate the amount of opioid medication required to provide pain relief

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

Find a Location

Who is running the clinical trial?

Archit SharmaLead Sponsor
Archit Sharma, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Administration of Lidocaine Post Cardiac Surgery via ESP Catheter Clinical Trial Eligibility Overview. Trial Name: NCT04995497 — Phase 2
Pain Management Research Study Groups: Erector Spinae Plane Block-Administration of Lidocaine, Intravenous-Administration of Lidocaine
Pain Management Clinical Trial 2023: Administration of Lidocaine Post Cardiac Surgery via ESP Catheter Highlights & Side Effects. Trial Name: NCT04995497 — Phase 2
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995497 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly participants eligible for this experiment?

"Individuals aged between 18 and 69 are qualified to be included in this study."

Answered by AI

Is access to this medical trial still available for potential participants?

"As published on clinicaltrials.gov, this trial is currently seeking participants - it was initially posted to the website on August 15th 2021 and most recently modified on September 23rd 2022."

Answered by AI

What therapeutic purposes does Adminstration of Lidocaine Post Cardiac Surgery via ESP Catheter typically serve?

"Lidocaine Post Cardiac Surgery via ESP Catheter is traditionally used to manage cervical syndrome, yet it can also ameliorate minor burns, transplantation-related symptoms and the effects of osteoporosis."

Answered by AI

Who is eligible to partake in this research program?

"In order to be admitted into this clinical trial, prospective participants must suffer from post-operative pain and have a chronological age between 18 and 69. Currently, the study is enlisting 70 people in total."

Answered by AI

How has the implementation of lidocaine via an ESP Catheter impacted cardiac surgery outcomes in past studies?

"Presently, 118 clinical trials are in progress investigating the efficacy of administering lidocaine post cardiac surgery via ESP Catheter. Of those, 31 have reached Phase 3 status. Although most experiments for this treatment take place in Calgary, Alberta; there exist 1,094 trial sites around the world."

Answered by AI

What is the capacity for participants in this experiment?

"Affirmative. Per the clinicaltrials.gov website, this medical trial is still recruiting patients with enrolment beginning on August 15th 2021 and updated on September 23rd 2022. 70 participants are being accepted from one location."

Answered by AI

To what extent has the FDA sanctioned the use of lidocaine through an ESP Catheter after cardiac surgery?

"Due to the Phase 2 status of this trial, our team at Power gave Administration of Lidocaine Post Cardiac Surgery via ESP Catheter a score of two on their safety scale. This signifies that there is some evidence supporting its security but none for efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Archit Sharma 2021. "Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995497.
~19 spots leftby Apr 2025
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