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

NCT ID: NCT03545854

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The cadavers will be randomized to receive the intervention (Erector Spinae Plane Block) on different levels (Vertebral level - T3, T12 and L4) and different volumes (10, 20 and 30ml)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T3 10ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

T3 20ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T3 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

T3 30ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T3 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

T12 10ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T12 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

T12 20ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T12 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

T12 30ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T12 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

L4 10ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the L4 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

L4 20ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the L4 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

L4 30ml

The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the L4 vertebral level

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

Interventions

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Erector Spinae Plane Block

Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irmandade da Santa Casa de Misericordia de Sao Paulo

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Vaz Perez

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre L Casale, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate

Locations

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Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Marcelo V Perez, PhD

Role: CONTACT

+551121767000

References

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Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

Reference Type BACKGROUND
PMID: 28919152 (View on PubMed)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750.

Reference Type BACKGROUND
PMID: 29561295 (View on PubMed)

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

Reference Type BACKGROUND
PMID: 28252539 (View on PubMed)

Leyva FM, Mendiola WE, Bonilla AJ, Cubillos J, Moreno DA, Chin KJ. Continuous Erector Spinae Plane (ESP) Block for Postoperative Analgesia after Minimally Invasive Mitral Valve Surgery. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2271-2274. doi: 10.1053/j.jvca.2017.12.020. Epub 2017 Dec 12. No abstract available.

Reference Type BACKGROUND
PMID: 29336964 (View on PubMed)

Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.

Reference Type BACKGROUND
PMID: 28203765 (View on PubMed)

Gaio-Lima C, Costa CC, Moreira JB, Lemos TS, Trindade HL. Continuous erector spinae plane block for analgesia in pediatric thoracic surgery: A case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):287-290. doi: 10.1016/j.redar.2017.11.010. Epub 2018 Jan 19. English, Spanish.

Reference Type BACKGROUND
PMID: 29370900 (View on PubMed)

Nandhakumar A, Nair A, Bharath VK, Kalingarayar S, Ramaswamy BP, Dhatchinamoorthi D. Erector spinae plane block may aid weaning from mechanical ventilation in patients with multiple rib fractures: Case report of two cases. Indian J Anaesth. 2018 Feb;62(2):139-141. doi: 10.4103/ija.IJA_599_17.

Reference Type BACKGROUND
PMID: 29491521 (View on PubMed)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Reference Type BACKGROUND
PMID: 28188621 (View on PubMed)

Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

Reference Type BACKGROUND
PMID: 28272292 (View on PubMed)

Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.

Reference Type BACKGROUND
PMID: 29670771 (View on PubMed)

Aksu C, Gurkan Y. Ultrasound-guided bilateral erector spinae plane block could provide effective postoperative analgesia in laparoscopic cholecystectomy in paediatric patients. Anaesth Crit Care Pain Med. 2019 Feb;38(1):87-88. doi: 10.1016/j.accpm.2018.03.008. Epub 2018 Apr 6. No abstract available.

Reference Type BACKGROUND
PMID: 29630940 (View on PubMed)

Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.

Reference Type BACKGROUND
PMID: 28727597 (View on PubMed)

Tulgar S, Senturk O. Ultrasound guided low thoracic erector spinae plane block for postoperative analgesia in radical retropubic prostatectomy, a new indication. J Clin Anesth. 2018 Jun;47:4. doi: 10.1016/j.jclinane.2018.02.013. Epub 2018 Mar 5. No abstract available.

Reference Type BACKGROUND
PMID: 29518667 (View on PubMed)

Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.

Reference Type BACKGROUND
PMID: 29149734 (View on PubMed)

Ueshima H, Hiroshi O. RETRACTED: Transapical transcatheter aortic valve implantation performed with an erector spinae plane block. J Clin Anesth. 2018 May;46:84. doi: 10.1016/j.jclinane.2018.02.001. Epub 2018 Feb 3. No abstract available.

Reference Type BACKGROUND
PMID: 29414628 (View on PubMed)

Ueshima H. RETRACTED: Pneumothorax after the erector spinae plane block. J Clin Anesth. 2018 Aug;48:12. doi: 10.1016/j.jclinane.2018.04.009. Epub 2018 Apr 21. No abstract available.

Reference Type BACKGROUND
PMID: 29684727 (View on PubMed)

Ueshima H, Hiroshi O. RETRACTED: Spread of local anesthetic solution in the erector spinae plane block. J Clin Anesth. 2018 Mar;45:23. doi: 10.1016/j.jclinane.2017.12.007. Epub 2017 Dec 16. No abstract available.

Reference Type BACKGROUND
PMID: 29258057 (View on PubMed)

Other Identifiers

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Erector Spinae Plane Block

Identifier Type: -

Identifier Source: org_study_id

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