IV Lidocaine vs. ESP Block for Postoperative Pain

Overseen By Rakesh Sondekoppam Vijayashankar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Archit Sharma

Must not be taking: Narcotics

Disqualifiers: Liver dysfunction, Kidney dysfunction, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are dependent on narcotics (opioids) or have chronic pain, you may not be eligible to participate.

What data supports the effectiveness of the drug lidocaine for postoperative pain management after cardiac surgery?

Research shows that lidocaine, when used in combination with other pain relief methods like fentanyl, can help reduce pain after heart surgery. Additionally, intravenous lidocaine is being explored as a way to manage pain after surgery, although its effectiveness can vary depending on the type of surgery. ^{1 2 3 4 5}

Is intravenous lidocaine safe for postoperative pain management?

Intravenous lidocaine is generally safe for managing postoperative pain, but it can have side effects like low blood pressure, headache, and vomiting. Serious side effects, though rare, can include heart problems and seizures, so careful monitoring is recommended. ^{1 6 7 8 9}

How does the drug intravenous lidocaine differ from other treatments for postoperative pain?

Intravenous lidocaine is unique because it is administered directly into the bloodstream and is used as part of a multimodal pain management strategy to reduce opioid use after surgery. Unlike other local anesthetics, it is considered a 'high-risk' medicine and requires careful dosing and monitoring to avoid serious side effects. ^{3 5 7 8 10}

Research Team

Archit Sharma, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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.

Inclusion Criteria

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

English speaking

Exclusion Criteria

Inability to provide informed consent

Prisoner status

Emergency surgery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous or erector spinae plane block administration of lidocaine for pain management post-cardiac surgery

48 hours

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and lidocaine plasma levels

2 weeks

1-2 visits (in-person)

Treatment Details

Interventions

• Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
• Intravenous Administration of Lidocaine Post Cardiac Surgery

Trial Overview 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.

Participant Groups

Group I: Erector Spinae Plane Block-Administration of Lidocaine Experimental Treatment 1 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 Lidocaine Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Archit Sharma

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

Intravenous lidocaine is emerging as a multimodal analgesic therapy that can help reduce the need for opioids after surgery, which is important for improving patient care and safety.

The article provides insights from a Veterans Affairs hospital's experience with implementing intravenous lidocaine, highlighting the need for educational resources and protocols to support nurses in managing this treatment effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management. Hunter, OO., Wong, A., Leng, J., et al.[2021]

In a study of 298 adult patients receiving intravenous lidocaine for postoperative pain, 58.4% experienced adverse effects, with nausea being the most common, but only 12.8% discontinued treatment due to these effects, indicating that lidocaine is generally well-tolerated.

The use of intravenous lidocaine significantly reduced opioid consumption and pain scores within the first day post-infusion, suggesting it is an effective adjunct for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain. Schuler, BR., Lupi, KE., Szumita, PM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systemic Absorption of Lidocaine from Continuous Erector Spinae Plane Catheters After Congenital Cardiac Surgery: A Retrospective Study. [2021]

2. Pakistan pubmed.ncbi.nlm.nih.gov

The effect of bilateral intrapleural infusion of lidocaine with fentanyl versus only lidocaine in relieving pain after coronary artery bypasses surgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative pain treatment with erector spinae plane block and pectoralis nerve blocks in patients undergoing mitral/tricuspid valve repair - a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Perioperative Intravenous Lidocaine as Part of an Abdominal Surgery Enhanced Recovery Pathway Does Not Significantly Impact Postoperative Pain. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Continuous Incisional Lidocaine in Pediatric Patients following Open Heart Surgery. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Intraoperative intravenous lidocaine. [2022]