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NCT06843343 · ClinicalTrials.gov registry record · Phase 4
Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT06843343 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 13 participants.
The verdict
NCT06843343, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
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
Interventions
- PROCEDURE Intertransverse Process Block with 1.5% Lidocaine
- PROCEDURE Erector Spinae Plane Block with 1.5% Lidocaine
- DRUG 1.5% Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2025-06-10 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06843343
The ClinicalTrials.gov registry entry for NCT06843343 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Intertransverse Process Block with 1.5% Lidocaine is the first listed.
NCT06843343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06843343 about?
NCT06843343 is a clinical study titled "Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study". 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. Alternati...
What is the current status of trial NCT06843343?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2025-06-10. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT06843343?
The interventions under investigation include: Intertransverse Process Block with 1.5% Lidocaine (PROCEDURE), Erector Spinae Plane Block with 1.5% Lidocaine (PROCEDURE), 1.5% Lidocaine (DRUG).
Who is sponsoring clinical trial NCT06843343?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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