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

NCT03545854 | Unknown

• 1 other identifier: Erector Spinae Plane Block
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

• Spread of Coloring Solution secondary to volume injected and vertebral level of injection

  Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected and injection site.

  3 hours

Secondary Outcomes (1)

• Spread of coloring solution to paravertebral space

  3 hours

Study Arms (9)

T3 10ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

T3 20ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

T3 30ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

T12 10ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

T12 20ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

T12 30ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

L4 10ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

L4 20ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

L4 30ml

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block 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; L4 20ml; L4 30ml; T12 10ml; T12 20ml; T12 30ml; T3 10ml; T3 20ml; T3 30ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-010, Brazil

Location

Related Publications (18)

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 29561295 BACKGROUND

• 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.

  PMID: 28252539 BACKGROUND

• 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.

  PMID: 29336964 BACKGROUND

• 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.

  PMID: 28203765 BACKGROUND

• 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.

  PMID: 29370900 BACKGROUND

• 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.

  PMID: 29491521 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  PMID: 28272292 BACKGROUND

• 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.

  PMID: 29670771 BACKGROUND

• 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.

  PMID: 29630940 BACKGROUND

• 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.

  PMID: 28727597 BACKGROUND

• 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.

  PMID: 29518667 BACKGROUND

• 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.

  PMID: 29149734 BACKGROUND

• 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.

  PMID: 29414628 BACKGROUND

• 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.

  PMID: 29684727 BACKGROUND

• 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.

  PMID: 29258057 BACKGROUND

• 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.

  PMID: 28919152 BACKGROUND

Study Officials

• Andre L Casale, MD

  Post Graduate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo V Perez, PhD

CONTACT

+551121767000; marcelovazperez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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)

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: June 4, 2018
• Study Start: August 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)