Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study
Key facts
- Who runs it
- Duke University
- Where
- Durham, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 13 people enrolled
- Started
- 10 Jun 2025
- Ended
- 1 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Intertransverse Process Block with 1.5% Lidocaine
- Erector Spinae Plane Block with 1.5% Lidocaine
- 1.5% Lidocaine
- Record updated
- 28 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Ability to provide written informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- ASA physical status 1 or 2
- Age ≥ 18 years
Who cannot take part
- History of thoracic trauma or surgery
- Systemic neuromuscular disease
- Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)
- Other known health conditions that would affect the participant's ability to successfully complete the study
- BMI > 35kg.m2
- Use of analgesics within 24 hours before the procedure
- Thoracic deformities or abnormalities that may prevent proper block performance
- Thoracic tattoos
Where in United States
- Duke University Medical CenterDurham, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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).
The 2 groups in the trial
- Erector Spinae Plane (ESP) BlockExisting treatment, for comparison
Participants receive ESP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on one visit.
Treatment: Erector Spinae Plane Block with 1.5% Lidocaine and 1.5% Lidocaine
- Intertransverse Process Block (ITP) BlockTreatment being tested
Participants receive ITP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on the other visit.
Treatment: Intertransverse Process Block with 1.5% Lidocaine and 1.5% Lidocaine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Erector Spinae Plane Block Versus Intertransverse Process Block: a Randomized Control Trial in Healthy Volunteers
- Record updated
- 28 August 2025