Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study

NCT06843343 | Completed Phase 4 FDA Drug

• 1 other identifier: Pro00117414
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Acute Pain, Postoperative; Regional Anesthesia Block

Keywords

Erector Spinae Plane Block; ESP Block; ESP; Intertransverse Block; ITP Block; ITP; Regional Anesthesia; Paraspinal Blocks

Outcome Measures

Primary Outcomes (3)

• Temperature discrimination

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

  60 to 90 minutes post-block

• Mechanical discrimination

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

  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.

  60 to 90 minutes post-block

Secondary Outcomes (4)

• Thermography

  Baseline and 60 to 90 minutes post-block

• Nociceptive discrimination

  Baseline and 60 to 90 minutes post-block

• Pulmonary Function Test

  Baseline and 60 to 90 minutes post-block

• Lidocaine pharmacokinetics

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

Other Outcomes (1)

• Adverse Events

  End of study (2 days post blocks).

Study Arms (2)

Erector Spinae Plane (ESP) Block

ACTIVE COMPARATOR

Participants receive ESP Block under ultrasound guidance, with 20mL of 1.5% Lidocaine on one visit.

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.

Procedure: Intertransverse Process Block with 1.5% Lidocaine; Drug: 1.5% Lidocaine

Interventions

Intertransverse Process Block with 1.5% Lidocaine PROCEDURE

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.

Intertransverse Process Block (ITP) Block

Erector Spinae Plane Block with 1.5% Lidocaine PROCEDURE

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.

Erector Spinae Plane (ESP) Block

1.5% Lidocaine DRUG

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

Erector Spinae Plane (ESP) Block; Intertransverse Process Block (ITP) Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian Mendelson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: June 10, 2025
• Primary Completion: July 26, 2025
• Study Completion: August 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)