Clinical trial NCT02911168: Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks
Official title: A Prospective, Randomized Comparison Between the Ultrasound Guided Paravertebral Block and the Ultrasound Guided Proximal Intercostal Nerve Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: NERVE BLOCK
ANESTHESIA RECOVERY PERIOD
PAIN MANAGEMENT
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Coagulopathy
2. Patient refusal
3. Allergy to local anesthetics

Primary outcomes:
measure: Ultrasound Image Quality Score
timeFrame: Evaluated at time of block
Secondary outcomes:
measure: Block Performance Time
timeFrame: Evaluated at time of block
measure: Imaging Time
timeFrame: Established during block performance
measure: Needling Time
timeFrame: Established during block performance
measure: Number of Needle Passes
timeFrame: Established during block performance
measure: Distance of Injection Sites from Midline
timeFrame: Established during block performance
measure: Presence of Perioperative Block-Related Complications
timeFrame: Within 24 hours of block placement
measure: Effectiveness of the Block
timeFrame: One hour following extubation, and at 24 hours following block placement
measure: Dermatomal spread
timeFrame: One hour following extubation
measure: Opioid requirement
timeFrame: Evaluated at 1 hour after extubation, and then at 24 hours following the block
measure: Prolonged postoperative pain
timeFrame: 6 and 12 months after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kamen Vlassakov, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Vlassakov K, Vafai A, Ende D, Patton ME, Kapoor S, Chowdhury A, Macias A, Zeballos J, Janfaza DR, Pentakota S, Schreiber KL. A prospective, randomized comparison of ultrasonographic visualization of proximal intercostal block vs paravertebral block. BMC Anesthesiol. 2020 Jan 9;20(1):13. doi: 10.1186/s12871-020-0929-x.