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Acute Pain, PostoperativePhase 4DEVILSNCT06843343

Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study

A Phase 4 study testing Intertransverse Process Block with 1.5% Lidocaine, Erector Spinae Plane Block with 1.5% Lidocaine and 1.5% Lidocaine in people with Acute Pain, Postoperative and Regional Anesthesia Block, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Intertransverse Process Block with 1.5% Lidocaine, Erector Spinae Plane Block with 1.5% Lidocaine and 1.5% Lidocaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
10 Jun 2025to 1 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 join

  • BMI > 35kg.m2
  • Use of analgesics within 24 hours before the procedure
  • History of thoracic trauma or surgery
  • Thoracic deformities or abnormalities that may prevent proper block performance
  • Thoracic tattoos
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Medical Center

    Durham, North Carolina, 27701

Other trials in United States

About this study

Official title: Erector Spinae Plane Block Versus Intertransverse Process Block: a Randomized Control Trial in Healthy Volunteers

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.

Read more

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).

Being tested
Intertransverse Process Block with 1.5% Lidocaine, Erector Spinae Plane Block with 1.5% Lidocaine, 1.5% Lidocaine
Keywords
Erector Spinae Plane Block, ESP Block, ESP, Intertransverse Block, ITP Block, ITP, Regional Anesthesia, Paraspinal Blocks
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intertransverse Process Block with 1.5% LidocaineProcedure or surgery

    For the ITP block, the needle will be advanced further into the intertransverse tissue complex between the T4 and T5 transverse processes, and local anesthetic will be injected just above the superior costotransverse ligament, under ultrasound guidance.

  • Erector Spinae Plane Block with 1.5% LidocaineProcedure or surgery

    The ESP block will be performed by advancing the needle to the transverse process, under ultrasound guidance, with local anesthetic injected between the erector spinae muscle and the transverse process, targeting a caudad-cephalad spread.

  • 1.5% LidocaineDrug

    local anesthetic to be used in either the ITP and ESP block

Study groups in NCT06843343
Study groupRoleWhat they receive
Erector Spinae Plane (ESP) BlockActive comparatorParticipants receive ESP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on one visit.
Receives: Procedure: Erector Spinae Plane Block with 1.5% Lidocaine; Drug: 1.5% Lidocaine
Intertransverse Process Block (ITP) BlockExperimentalParticipants receive ITP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on the other visit.
Receives: Procedure: Intertransverse Process Block with 1.5% Lidocaine; Drug: 1.5% Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temperature discrimination

    Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.

    Measured: 60 to 90 minutes post-block

  2. Mechanical discrimination

    Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.

    Measured: 60 to 90 minutes post-block

  3. Cutaneous distribution mapping

    Mapping the blocked area (using the previous temperature and mechanical assessments, demarcating lines on the skin) to provide a visual map and, to calculate the area blocked.

    Measured: 60 to 90 minutes post-block

Secondary outcomes (4)
  1. Thermography

    Infrared camera will assess skin temperature of the chest wall.

    Measured: Baseline and 60 to 90 minutes post-block

  2. Nociceptive discrimination

    Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.

    Measured: Baseline and 60 to 90 minutes post-block

  3. Pulmonary Function Test

    Peak Flow.

    Measured: Baseline and 60 to 90 minutes post-block

  4. Lidocaine pharmacokinetics

    Calculate lidocaine systemic absorption (Cmax).

    Measured: Basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start10 Jun 2025
  3. Primary completion26 Jul 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843343
Sponsor's protocol ID
Pro00117414
Acronym
DEVILS
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intertransverse Process Block with 1.5% Lidocaine, Erector Spinae Plane Block with 1.5% Lidocaine and 1.5% Lidocaine in people with Acute Pain, Postoperative and Regional Anesthesia Block, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature discrimination (time frame: 60 to 90 minutes post-block). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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