Lidocaine Blocks for Regional Anesthesia

(DEVILS Trial)

Overseen By Sara Amaral, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Analgesics

Disqualifiers: BMI > 35, Thoracic trauma, 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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to numb a specific chest area using the local anesthetic lidocaine. It compares two types of nerve blocks: the Erector Spinae Plane (ESP) block and the Intertransverse Process (ITP) block, to determine which provides better skin coverage. Researchers aim to understand how each method affects lidocaine absorption in the body to ensure safety. Participants should be healthy adults who have not undergone chest surgery or trauma and are not using pain medications before the procedure. As a Phase 4 trial, this research focuses on an FDA-approved treatment to assess its benefits for a broader patient population.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not use any pain relievers (analgesics) within 24 hours before the procedure. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Research has shown that the Erector Spinae Plane (ESP) block is generally safe. In 19 reviewed studies, no complications were reported, indicating it is well-tolerated for pain relief during surgery. This suggests it is likely a safe option for reducing pain in the chest area.

For the Intertransverse Process (ITP) block, specific safety information is less available. However, both the ESP and ITP blocks use ultrasound guidance and similar amounts of lidocaine, implying that the ITP block might also be safe. More direct evidence would be beneficial.

Overall, since this trial is in Phase 4, both blocks have already undergone earlier testing phases for safety. Treatments in this phase have usually proven to be quite safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore new ways to deliver lidocaine for regional anesthesia, potentially offering more precise pain control. Unlike traditional methods that often involve systemic pain management, these blocks—Erector Spinae Plane (ESP) Block and Intertransverse Process (ITP) Block—use ultrasound guidance to target specific nerves directly. This approach could mean faster pain relief, reduced side effects, and a more localized effect, which are significant improvements over standard systemic analgesics. By honing in on precise areas, these blocks might provide better pain management for patients undergoing surgery or dealing with chronic pain conditions.

What evidence suggests that these nerve block techniques are effective for regional anesthesia?

Research has shown that the Erector Spinae Plane (ESP) block, one of the treatments in this trial, effectively reduces pain and decreases the need for opioids after surgery. It is particularly useful for managing pain following lower back surgery. The Intertransverse Process (ITP) block, another treatment option in this trial, is a newer method designed to provide more precise pain relief. Studies suggest it might control pain more broadly by affecting several nerve areas. Both techniques in this trial use lidocaine, a local anesthetic, to numb the area and aid in pain management. They are considered safe and promising options for regional anesthesia. ^{1 2 6 7 8}

Who Is on the Research Team?

Brian Mendelson, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for healthy adult volunteers interested in helping compare two regional anesthesia techniques for chest wall pain relief. Participants should be available for two separate procedure days and willing to undergo sensory testing and blood draws.

Inclusion Criteria

I am in good or mild systemic disease condition.

Ability to provide written informed consent

Ability and willingness to comply with the study procedures and duration requirements

Exclusion Criteria

BMI > 35kg/m2

Thoracic deformities or abnormalities that may prevent proper block performance

Thoracic tattoos

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Procedure Day 1

Participants receive either an ESP or ITP block under ultrasound guidance, with sensory testing and blood sampling for lidocaine PK analysis

1 day

1 visit (in-person)

Procedure Day 2

Participants receive the alternate block (ESP or ITP) under ultrasound guidance, with sensory testing and blood sampling for lidocaine PK analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and block-related outcomes

2 days post blocks

What Are the Treatments Tested in This Trial?

Interventions

• 1.5% Lidocaine
• Erector Spinae Plane Block with 1.5% Lidocaine
• Intertransverse Process Block with 1.5% Lidocaine

Trial Overview The study tests the distribution of numbness caused by two nerve block techniques, ESP and ITP, using Lidocaine. It also examines how Lidocaine is absorbed into the body with each technique. Volunteers will receive both blocks on different days.

How Is the Trial Designed?

Group I: Intertransverse Process Block (ITP) Block Experimental Treatment 2 Interventions

Participants receive ITP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on the other visit.

Group II: Erector Spinae Plane (ESP) Block Active Control 2 Interventions

Participants receive ESP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on one visit.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The erector spinae plane block is a technique where local anesthetic is injected to provide pain relief in various regions, including thoracic, abdominal, and lumbar areas.

This study reports the first successful use of a bilateral erector spinae plane block for surgical anesthesia in the cervical region, expanding its potential applications in anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Block for Surgery on the Posterior Aspect of the Neck: A Case Report. Evans, HT., Leslie, GJ., Rutka, O., et al.[2021]

In a case series of 10 patients undergoing bilateral erector spinae plane (ESP) block for lumbar spine surgery, lidocaine showed a rapid absorption with peak concentrations (Cmax) ranging from 1.2 to 3.8 mg/L, which remained below toxicity limits.

The pharmacokinetics of lidocaine after ESP block indicated high bioavailability (average AUC0-3 of 76%) and a slightly prolonged elimination half-life in older patients, suggesting that age may influence drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. De Cassai, A., Bonanno, C., Padrini, R., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04401007

Erector Spinae Plane (ESP) Block Volunteer Study The goal of this study is to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164397/

Erector Spinae Plane Block for Perioperative Pain Management This meta-analysis demonstrated that ESPB used in lumbar spinal surgery was effective in relieving postoperative pain, decreasing the perioperative consumption ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818024001570

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.

4. jss.amegroups.org jss.amegroups.org/article/view/6328/html

Narrative review: erector spinae block in spine surgery Erector spinae block was found in general to lower postoperative opioid use compared to traditional anesthesia.

5. tandfonline.com tandfonline.com/doi/full/10.1080/11101849.2023.2222471

Full article: Efficacy of different local anaesthetic volumes ... Erector spinae plane block [ESPB] was reported to be a successful method to reduce pain scores and consumption of postoperative opioids. However ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6547235/

The erector spinae plane block: a narrative review - PMC USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04221880

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 ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01860-w

Analgesia and spread of erector spinae plane block in ... Analgesic efficacy and safety of erector spinae plane block in breast cancer surgery: a systematic review and meta-analysis. BMC Anesthesiol ...