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

Nerve Block Clinical Trial

Official title:

Determination of Relationship Between Volume and Dispersion of Local Anesthetic on Ultrasound-guided Erector Spinae Plane Block in Cadavers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03545854
• Other study ID #: Erector Spinae Plane Block
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2018
• Source: Federal University of São Paulo
• Contact: Marcelo V Perez, PhD
• Phone: +551121767000
• Email: marcelovazperez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cadaver
• Nerve Block

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

Aksu C, Gürkan Y. Ultrasound-guided bilateral erector spinae plane block could provide effective postoperative analgesia in laparoscopic cholecystectomy in paediatric patients. Anaesth Crit Care Pain Med. 2018 Apr 6. pii: S2352-5568(18)30084-5. doi: 10.1016/j.accpm.2018.03.008. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2018 May;65(5):287-290. doi: 10.1016/j.redar.2017.11.010. Epub 2018 Jan 19. English, Spanish. — View Citation

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. — View Citation

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. 2017 Dec 12. pii: S1053-0770(17)31005-4. doi: 10.1053/j.jvca.2017.12.020. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ueshima H, Hiroshi O. 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. — View Citation

Ueshima H, Hiroshi O. 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. — View Citation

Ueshima H. Pneumothorax after the erector spinae plane block. J Clin Anesth. 2018 Apr 20;48:12. doi: 10.1016/j.jclinane.2018.04.009. [Epub ahead of print] — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spread of coloring solution to paravertebral space	Observation of coloring solution on the paravertebral space. Comparison of number of levels of the paravertebral space colored according to volume injected and injection site.	3 hours