IV Lidocaine vs. ESP Block for Postoperative Pain

AS
RS
Overseen ByRakesh Sondekoppam Vijayashankar, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of using lidocaine for pain relief after heart surgery. One method delivers lidocaine through a catheter placed near the spine, while the other uses an intravenous (IV) route. Researchers aim to determine which method provides better pain relief. Individuals undergoing planned heart surgery, such as a coronary artery bypass graft (CABG) or valve surgery, and who speak English, may qualify for this trial. As a Phase 2 trial, the study measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important pain management research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the erector spinae plane (ESP) block with lidocaine is generally well-tolerated. A review of studies found it can reduce the need for painkillers like opioids after surgery and aid in faster recovery, such as quicker removal from a breathing machine and earlier mobility. However, limited information exists about its effects on children, so researchers mostly study it in adults.

For intravenous lidocaine, research has shown it can reduce pain after surgery and speed up recovery. A detailed review of many studies found it lessens pain soon after surgery. However, it must be used carefully, as rare reports of serious side effects have occurred if not used properly.

Both treatments have shown benefits in managing pain after surgery, but they should be used under medical supervision to ensure safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore two unique methods of delivering lidocaine for managing postoperative pain after cardiac surgery. Unlike the standard intravenous (IV) administration that is commonly used, the Erector Spinae Plane (ESP) Block involves a targeted delivery directly near the spine with the help of ultrasound guidance, potentially offering more localized pain control. This regional anesthetic technique might reduce the overall requirement for pain medications and enhance recovery. On the other hand, the intravenous administration of lidocaine remains the more familiar route but is being carefully compared to see if one method offers superior pain relief or fewer side effects. By investigating these approaches, researchers hope to optimize pain management and improve patient outcomes after heart surgeries.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare two methods of administering lidocaine for postoperative pain management. Research has shown that using an erector spinae plane (ESP) block with lidocaine, which participants in one arm of this trial may receive, can reduce the need for opioids, lower pain levels, and delay the first request for pain relief after surgery. This method has been successful in various surgeries, aiding in pain management and speeding up recovery. In contrast, participants in another arm of this trial will receive intravenous lidocaine, known for reducing moderate-to-severe pain after surgery, especially during movement. Studies indicate it can effectively manage pain for up to 48 hours post-surgery. Both treatments hold promise for managing postoperative pain, with each offering advantages depending on the type of surgery.46789

Who Is on the Research Team?

AS

Archit Sharma, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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
See 14 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Erector Spinae Plane Block-Administration of LidocaineExperimental Treatment1 Intervention
Group II: Intravenous-Administration of LidocaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Archit Sharma

Lead Sponsor

Trials
1
Recruited
70+

Published Research Related to This Trial

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.
Evaluating the Safety of Continuous Infusion Lidocaine for Postoperative Pain.Schuler, BR., Lupi, KE., Szumita, PM., et al.[2023]
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.
Educating Nurses on Intravenous Lidocaine for Postoperative Pain Management.Hunter, OO., Wong, A., Leng, J., et al.[2021]

Citations

Efficacy of erector spinae plane block for postoperative ...ESP block provides less opioid consumption and PONV, lower pain scores, and longer time to first analgesic request in patients undergoing lumbar surgery.
A randomized clinical trial of erector spinae plane block ...The primary hypothesis of this study was that ESPB reduces the incidence of chronic pain for 3 months after posterior lumbar surgery.
Study Details | Erector Spinae Plane Block Versus ...Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries. The investigators aimed to ...
Erector spinae plane block improves postoperative recovery ...Our hypothesis is that the ESP block will decrease length of stay (LOS), reduce opioid need and improve numeric rating scale (NRS) pain scores.
Erector Spinae Plane Block in Multimodal Analgesia After...This study evaluated the effect of bilateral ESPB on early postoperative pain and opioid use after lumbar spinal fusion surgery.
Erector Spinae Plane Block for Postoperative Analgesia in ...This systematic review and meta-analysis demonstrated that ESPB provides opioid-sparing perioperative analgesia, facilitates early extubation and mobilization, ...
Postoperative Outcomes of Analgesic Management with ...There is limited evidence on the impact of erector spinae plane block (ESPB) as part of multimodal analgesia in pediatric population ...
Systemic lidocaine versus erector spinae plane block for ...Intravenous lidocaine provides a non-inferior quality of recovery compared to ESPB without requiring specialized regional anesthesia procedures.
Systemic Absorption of Lidocaine from Continuous Erector ...Objectives: To examine postoperative serum lidocaine levels in patients with intermittent lidocaine bolus erector spinae plane block (ESPB) catheters after ...
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