Lidocaine Blocks for Regional Anesthesia
(DEVILS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the chest wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. Alternative peripheral nerve block techniques, such as intercostal nerve blocks, eliminate the neuraxial complications but, in turn, require numerous injections to provide unilateral coverage. The introduction of ultrasound-guided (USG) nerve blocks has generated clinical interest in the development of novel paraspinal (non-epidural) nerve block techniques, which will provide multiple dermatomal coverage with a single injection. Two such techniques are the Erector Spinae Plane (ESP) block and the Intertransverse Process (ITP) block. The Intertransverse Process (ITP) block targets a slightly deeper plane than the Erector Spinae Plane (ESP) block and was specifically designed to address the ESP block's variable anesthetic spread. Despite its potential for more localized and precise dermatomal coverage, no prior studies have directly compared the two techniques in terms of their cutaneous distribution.Thus, this randomized, double-blinded trial aims to compare the cutaneous distribution of both these blocks in healthy adult volunteers. To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli.In addition to assessing the distribution and coverage of the ESP and ITP blocks, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the two blocks. Theoretically, there may be a difference in the anatomical target for both blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and both blocks should be similarly safe.A total of 14-18 healthy adult volunteers will be included. There will be two different procedure days, separated by at least one week. On each day, the subjects will receive a paraspinal block, according to the randomization process. Each volunteer will undergo pre-procedure screening on the first visit. The blocks will be performed on the same side, at the same level, by the same anesthesiologist, at least one week apart. An ultrasound-guided ESP block will be administered in one day, and an ITP block on the other. The order will be randomized, and both the subject and the research team member assessing the block will be blinded. Sensory testing will be performed at baseline and 60-90 minutes after the block injections. Serial samples of blood will be drawn to analyze lidocaine PK (between 0 and 240 minutes post-block).
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.
Is the use of lidocaine in erector spinae plane blocks generally safe for humans?
The erector spinae plane block, which uses lidocaine, is considered safe and is widely used in various surgeries. Although specific safety data is limited, many medical societies have endorsed its safety as an alternative to traditional anesthesia techniques, especially for patients at risk of complications.12345
How is the treatment with 1.5% Lidocaine for regional anesthesia unique?
This treatment is unique because it uses the erector spinae plane block, a relatively new technique where the anesthetic is injected near the spine to provide pain relief in various body regions, including the thoracic, abdominal, and lumbar areas. It is gaining popularity due to its versatility and potential for use in different surgical and pain management scenarios.12367
What data supports the effectiveness of the treatment 1.5% Lidocaine, Erector Spinae Plane Block with 1.5% Lidocaine, Intertransverse Process Block with 1.5% Lidocaine?
Research shows that the Erector Spinae Plane Block, which involves injecting a local anesthetic like lidocaine, has been effective in providing pain relief for surgeries in various body regions, including the thoracic and lumbar areas. This suggests that using lidocaine in this type of block can be effective for regional anesthesia.12389
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure Day 1
Participants receive either an ESP or ITP block under ultrasound guidance, with sensory testing and blood sampling for lidocaine PK analysis
Procedure Day 2
Participants receive the alternate block (ESP or ITP) under ultrasound guidance, with sensory testing and blood sampling for lidocaine PK analysis
Follow-up
Participants are monitored for adverse events and block-related outcomes
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor