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NCT Number: NCT02911168

Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks

The purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the classic paravertebral bock.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

Although previous studies have made advances towards applying ultrasound guidance to the performance of paravertebral blocks (PVB), a technique combining both safety and technical ease remains elusive. The ideal technique (1) permits continuous visualization of the entire needle shaft and tip, (2) avoids aiming the needle tip and injectate directly toward the neuraxis or lung, and (3) is easy to perform. Visualization of all structures by ultrasound is essential to minimize the risk of vascular puncture, nerve root or spinal cord injury, and pneumothorax. Failure to consistently and quickly identify the transverse process and pleura, as occurs when using older techniques, results in several needle redirections, causing pain and discomfort to patients, and increases the potential risk of pneumothorax. The technical difficulty of applying previously-described US-guided techniques takes an inordinate amount of time and is clinically less practical within a busy surgical practice.

In the current study, the investigators describe a novel, modified approach to real-time ultrasound-guided single shot paravertebral blockade, the proximal intercostal block (PICB), which utilizes a sagittal paramedian US probe placement to identify the intercostal space and PVS. In this method, instead of placing the probe at a fixed traditional distance of 2.5 cm from the spinous processes, the probe is moved laterally to obtain a comprehensive image, with a clear view of the ribs, internal intercostal membrane, and the parietal pleura.

The investigators propose that moving the probe laterally towards the proximal intercostal space allows clearer simultaneous visualization of both pleura and needle as it advances towards the PVS, while achieving comparable injectate spread and, ultimately, similar or better clinical results. Such improved visualization will reduce the number of needle passes, increase confidence in the user, decrease block placement time, and improve overall block success. This technique combines the advantages of more lateral approaches (better visualization of structures, in particular the pleura) with the advantage of the more medial approaches (in-plane, closer, and not directed at the neuraxis).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females age 18-85 years old
  • ASA 1-3
  • Patient scheduled for unilateral or bilateral mastectomy with or without reconstruction

Exclusion criteria

  • Coagulopathy
  • Patient refusal
  • Allergy to local anesthetics

Treatment and study plan

Proximal Intercostal Block

Procedure

After identifying the correct intercostal space, the ultrasound probe will be moved medially to identify the transverse processes, then again laterally from the transverse processes to rest over the ribs so as to obtain the best view of ribs and pleura. A 10cm, 21G needle will be inserted in-plane at the caudal border of the probe. An attempt will be made to keep the needle tip and the target injection position (just under the internal intercostal membrane (IIM)) in view. Correct needle tip placement will be demonstrated by depression of the pleura/endothoracic fascia upon local anesthetic injection and by lack of retrograde spread of LA over the muscles or the ribs. The LA will be injected in 4 cc aliquots after negative aspiration of air, CSF and blood.

Other names: PICB

paravertebral block

Procedure

After identifying the correct intercostal space, the ultrasound probe will be placed between the adjacent transverse processes in a longitudinal/parasagittal plane measuring 2.5cm from the midline. The best possible view of the transverse processes, the superior costotransverse ligament and pleura will be obtained. An attempt will be made to keep the needle tip and the target injection position (immediately beneath the costotransverse ligament) in view. Correct placement of the needle tip will be demonstrated by depression of the pleura upon injection of local anesthetic and by lack of retrograde spread of LA over the muscles or transverse processes. The LA will be injected in 4 cc aliquots after confirming negative aspiration of air, CSF and blood.

Other names: PVB

Primary outcomes

  1. Ultrasound Image Quality Score

    Time frame: Evaluated at time of block

    The following will be assessed for each image and video, and saved during each block performed:

    • Best possible image of block anatomy (including the pleura, transverse process/rib, costotransverse ligament/internal intercostal membrane, as appropriate) as well as needle location.
    • Video of the space during injection, reflecting the injectate spread. The images will be rated by a separate regional anesthesiologist not involved in study, but proficient with both types of blocks and ultrasound imaging.
    • The following score 3 point scale will be used to rate visibility: 0=not visible, 1=hardly visible, 2=well visible, 3=very well visible. Maximum score possible=18 including both pieces of media.

Secondary outcomes

  1. Block Performance Time

    Time frame: Evaluated at time of block

    Defined as the sum of imaging and needling times

  2. Imaging Time

    Time frame: Established during block performance

    Defined as the time interval between contact of the ultrasound probe with the patient, and the acquisition of a satisfactory image (which will be saved and analyzed later by a regional anesthesiologist blinded to the particular aims of the study).

  3. Needling Time

    Time frame: Established during block performance

    Defined as the time interval between the start of the skin wheal and the end of local anesthetic injection through the block needle.

  4. Number of Needle Passes

    Time frame: Established during block performance

    Initial needle insertion will be counted as "first pass". Any subsequent needle advancement, preceded by a retraction of more than 2 cm, will be counted as an additional pass.

  5. Distance of Injection Sites from Midline

    Time frame: Established during block performance

    Measured and recorded (one of our clinical aims)

  6. Presence of Perioperative Block-Related Complications

    Time frame: Within 24 hours of block placement

    The presence of the following complications will be recorded:

    • Horner's syndrome
    • Pneumothorax
    • Local anesthetic systemic toxicity (LAST)
    • Pain on injection
    • Evidence of contralateral block (for unilateral procedures)

  7. Effectiveness of the Block

    Time frame: One hour following extubation, and at 24 hours following block placement

    Patients will be asked to provide a verbal rating score of pain (0-10) at two time points: one hour following extubation, and 24h following block placement. At the 1 hour following extubation time point, we will be checking the coverage of the block in terms of dermatomal spread (see below).

  8. Dermatomal spread

    Time frame: One hour following extubation

    Number of dermatomal block levels, determined by loss of sensation to cold (ice) or to loss of pinprick sensation in the PACU one hour after extubation.

  9. Opioid requirement

    Time frame: Evaluated at 1 hour after extubation, and then at 24 hours following the block

    Opioid requirement, including intraoperative, PACU, and during the entire hospital admission, normalized to morphine equivalents.

  10. Prolonged postoperative pain

    Time frame: 6 and 12 months after surgery

    Postoperative contact via secure e-mail at will assess for the incidence of chronic pain.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

A Prospective, Randomized Comparison Between the Ultrasound Guided Paravertebral Block and the Ultrasound Guided Proximal Intercostal Nerve Block

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Sep 22, 2016
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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