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Dispersion of Local Anesthetic on the Erector Spinae Plane Block in Cadavers

F

Federal University of São Paulo

Status

Unknown

Conditions

Nerve Block

Treatments

Procedure: Erector Spinae Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT03545854
Erector Spinae Plane Block

Details and patient eligibility

About

This study aims to better understand the dispersion of local anesthetic on the Erector Spinae Block, a new technique developed for analgesia. It consists on injection of local anesthetic around the posterior muscles of the Spine. In this study, the investigators will make the injection with coloring solution on cadavers and by dissection will note the dispersion of the solution according to injectate volume. The investigators hypothesize more volume allows bigger spread and will allow new indications of this technique in perioperative analgesia and treatment of chronic Pain

Full description

The study's methodology will include performing ultrasound guided erector spinae block in cadavers included in the study according to eligibility criteria. After signing of written consent form, the participants will be randomized on the height of the block (vertebral level - T3, T12 and L4) and the volume to be injected (10, 20 and 30ml). The block will be performed by experienced physicians on the technique by ultrasound guidance and fixed pressure measured with an in-line pressure monitor (15 psi) with the cadaver in the lateral position. The cadavers will be submitted to autopsy by standard thoracoabdominal midline incision, with the viscera removed for analysis. The cadavers will have their paraspinal muscles removed (quadratus lumborum and psoas major), the medial parietal pleura opened and the number of levels with colored solution registered, noting the spread to ventral rami of spinal nerves and to the paravertebral space.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Fresh Cadavers (not subject to formaldehyde fixation process or frozen > 24h)
  • Age > 18 years
  • Written informed consent signed by responsible party
  • Height > 150cm and < 190cm

Exclusion criteria

  • Previous spinal surgery
  • Severe spinal deformity
  • BMI > 35 kg/m2
  • Absence of a responsible party to sign the written informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 9 patient groups

T3 10ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
T3 20ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T3 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
T3 30ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T3 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
T12 10ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T12 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
T12 20ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T12 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
T12 30ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T12 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
L4 10ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the L4 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
L4 20ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the L4 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block
L4 30ml
Experimental group
Description:
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the L4 vertebral level
Treatment:
Procedure: Erector Spinae Plane Block

Trial contacts and locations

1

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Central trial contact

Marcelo V Perez, PhD

Data sourced from clinicaltrials.gov

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