Nerve BlockNCT03545854
Dispersion of Local Anesthetic on the Erector Spinae Plane Block in Cadavers
A study testing Erector Spinae Plane Block in people with Nerve Block, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous spinal surgery
- Severe spinal deformity
- BMI > 35 kg/m2
- Absence of a responsible party to sign the written informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-010
About this study
Official title: Determination of Relationship Between Volume and Dispersion of Local Anesthetic on Ultrasound-guided Erector Spinae Plane Block in Cadavers
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
Read the detailed 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.
- Conditions
- Nerve Block
- Being tested
- Erector Spinae Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| T3 10ml | Experimental | The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (1)
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Principal investigator, Marcelo Vaz Perez, Federal University of São Paulo
- Investigators
- Andre L Casale, MD, Principal investigator, Post Graduate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545854
- Sponsor's protocol ID
- Erector Spinae Plane Block
- Status last verified
- May 2018
- First submitted
- 12 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research results will be published on indexed scientific journals, maintaining participant identity confidential
Publications
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.
PubMed 27501016Elsharkawy 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.
PubMed 29561295Forero 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.
PubMed 28252539Leyva 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.
PubMed 29336964Hamilton 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.
PubMed 28203765Gaio-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.
PubMed 29370900Nandhakumar 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.
PubMed 29491521Chin 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.
PubMed 28188621Chin 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.
PubMed 28272292Tulgar 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.
PubMed 29670771Aksu 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.
PubMed 29630940Restrepo-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.
PubMed 28727597Tulgar 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.
PubMed 29518667Tulgar 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.
PubMed 29149734Ueshima 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.
PubMed 29414628
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Relationship Between Volume and Dispersion of Local Anesthetic on Ultrasound-guided Erector Spinae Plane Block in Cadavers
- ClinicalTrials.gov ID
- NCT03545854
- Acronym / sponsor ID
- Erector Spinae Plane Block
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| T3 10ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level |
| T3 20ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T3 vertebral level |
| T3 30ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T3 vertebral level |
| T12 10ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T12 vertebral level |
| T12 20ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T12 vertebral level |
| T12 30ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T12 vertebral level |
| L4 10ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the L4 vertebral level |
| L4 20ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the L4 vertebral level |
| L4 30ml | Experimental | Procedure: Erector Spinae Plane BlockThe cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the L4 vertebral level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous spinal surgery
- Severe spinal deformity
- BMI > 35 kg/m2
- Absence of a responsible party to sign the written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockUltrasound 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. | Procedure or surgery | L4 10ml, L4 20ml, L4 30ml, T12 10ml, T12 20ml, T12 30ml, T3 10ml, T3 20ml, T3 30ml |
Primary outcome
Spread of Coloring Solution secondary to volume injected and vertebral level of injection
Time frame: 3 hours
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.
1 secondary outcome
Spread of coloring solution to paravertebral space
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 29561295Elsharkawy 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.
- Background: PubMed 28252539Forero 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.
- Background: PubMed 29336964Leyva 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.
- Background: PubMed 28203765Hamilton 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.
- Background: PubMed 29370900Gaio-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.
- Background: PubMed 29491521Nandhakumar 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.
- Background: PubMed 28188621Chin 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.
- Background: PubMed 28272292Chin 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.
- Background: PubMed 29670771Tulgar 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.
- Background: PubMed 29630940Aksu 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.
- Background: PubMed 28727597Restrepo-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.
- Individual participant dataSharing planned: No. The research results will be published on indexed scientific journals, maintaining participant identity confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre L Casale, MD principal investigator
Post Graduate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Nerve Block, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo V Perez, PhD (+551121767000, marcelovazperez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spread of Coloring Solution secondary to volume injected and vertebral level of injection (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545854, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.