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.
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
- Conditions the study is for
- Acute Pain, Postoperative, Regional Anesthesia Block
- 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
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 group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane (ESP) Block | Active comparator | Participants 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) Block | Experimental | Participants 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.
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
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
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)
Thermography
Infrared camera will assess skin temperature of the chest wall.
Measured: Baseline and 60 to 90 minutes post-block
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
Pulmonary Function Test
Peak Flow.
Measured: Baseline and 60 to 90 minutes post-block
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.
- First posted24 Feb 2025
- Study start10 Jun 2025
- Primary completion26 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Mendelson, MD, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Intertransverse Process Block: a Randomized Control Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06843343
- Acronym / sponsor ID
- DEVILS / Pro00117414
- Keywords
- Erector Spinae Plane Block, ESP Block, ESP, Intertransverse Block, ITP Block, ITP, Regional Anesthesia, Paraspinal Blocks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane (ESP) Block | Active comparator | Procedure: Erector Spinae Plane Block with 1.5% Lidocaine, Drug: 1.5% LidocaineParticipants receive ESP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on one visit. |
| Intertransverse Process Block (ITP) Block | Experimental | Procedure: Intertransverse Process Block with 1.5% Lidocaine, Drug: 1.5% LidocaineParticipants receive ITP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on the other visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intertransverse Process Block with 1.5% LidocaineFor 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. | Procedure or surgery | Intertransverse Process Block (ITP) Block |
| Erector Spinae Plane Block with 1.5% LidocaineThe 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. | Procedure or surgery | Erector Spinae Plane (ESP) Block |
| 1.5% Lidocainelocal anesthetic to be used in either the ITP and ESP block | Drug | Erector Spinae Plane (ESP) Block, Intertransverse Process Block (ITP) Block |
Primary outcome
Temperature discrimination
Time frame: 60 to 90 minutes post-block
Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.
Mechanical discrimination
Time frame: 60 to 90 minutes post-block
Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.
Cutaneous distribution mapping
Time frame: 60 to 90 minutes post-block
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.
4 secondary outcomes
Thermography
Time frame: Baseline and 60 to 90 minutes post-block
Nociceptive discrimination
Time frame: Baseline and 60 to 90 minutes post-block
Pulmonary Function Test
Time frame: Baseline and 60 to 90 minutes post-block
Lidocaine pharmacokinetics
Time frame: Basiline, 10, 20, 30, 45, 60, 90, 120 and 240 minutes post block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Mendelson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.