NCT04166188

Brief Summary

Erector spinae plane block (ESP block) was first described by Forero et al for the treatment of neuropathic chest pain. Total hip arthroplasty is a surgery with a high potential for severe postoperative pain, and greater attention should be paid to postoperative analgesia. There are multiple forms of postoperative analgesia for total hip arthroplasty, such as subarachnoid morphine, femoral nerve block, obturator and lateral femoral cutaneous block, lumbar plexus block, continuous epidural block, and "3 in 1" block, for example. ESP (LESP) block has emerged based on the same principle as the ESP block in the thoracic region. So far, to the best of our knowledge, there are only a few case reports that evidence its use for hip surgery analgesia. This study aimed to study the local anesthetic dispersion and the mechanism of action of the blockade. An experimental, analytical and prospective study will be carried out in which eight fresh adult human cadavers will be selected and injected with 20 ml of 0.01% methylene blue solution at L4 level. The injection will be performed with a Quincke 20G 100-150mm ultrasound-guided needle with a low-frequency curvilinear transducer (4-8 MHz - SonoSite) in the plane between the transverse process of L4 and the spinal erector muscle, bilaterally in each cadaver. by the same operator. After injection of the solution, the cadavers will be submitted to posterior lumbar region dissection by an anatomist and analyzed the dispersion and impregnation of the blue solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 5, 2021

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

November 11, 2019

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blue solution dispersion to the lumbar plexus in cadaver

    It will be injected 20ml of blue solution in the lumbar erector spinae plane of adult fresh cadavers, ultrasound guided, with posterior dissection of the lumbar region by a neurosurgeon and the investigators to evaluate the dispersion of the solution to the nerve roots of lumbar plexus, simulating a new anesthetic technique.

    7 months

Study Arms (1)

Cadavers

EXPERIMENTAL

20ml of 0.01% methylene blue solution (50mg of methylene blue diluted in 0.9% saline 500ml) will be injected, simulating the LESP block technique: injection between the transverse process of the fourth lumbar vertebra (L4) and the erector muscle of the underlying spine. The injection will be performed with a Quincke 20G 100-150mm ultrasound-guided needle with a low-frequency curvilinear transducer (4-8 MHz - SonoSite) in the plane between the transverse process of L4 and the spinal erector muscle, bilaterally in each cadaver. by the same operator. After injection of the solution the cadavers will be submitted to posterior lumbar region dissection by an anatomist and analyzed the dispersion and impregnation of the blue solution. The anatomical structures with the dye dispersion will be photographed and stored.

Procedure: Lumbar erector spinae plane block

Interventions

Injection of blue solution in the erector spinae plane in L4 ultrasound-guided and posterior dissection of the lumbar region.

Cadavers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fresh cadavers;
  • Age\> 18 years;
  • Height between 150cm and 190cm;
  • Any gender.

You may not qualify if:

  • Corpses with severe spinal deformity;
  • Known history of lumbar spine surgery;
  • Scars suggestive of large anatomical manipulations of the lumbar region;
  • Corpses with BMI\> 35 kg / m².

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Location

Related Publications (10)

  • Vidal E, Gimenez H, Forero M, Fajardo M. Erector spinae plane block: A cadaver study to determine its mechanism of action. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Nov;65(9):514-519. doi: 10.1016/j.redar.2018.07.004. Epub 2018 Aug 27. English, Spanish.

  • 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.

  • Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17.

  • Hamilton DL, Manickam B. The Erector Spinae Plane Block. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):276. doi: 10.1097/AAP.0000000000000565. No abstract available.

  • Foss NB, Kristensen MT, Palm H, Kehlet H. Postoperative pain after hip fracture is procedure specific. Br J Anaesth. 2009 Jan;102(1):111-6. doi: 10.1093/bja/aen345.

  • Ibrahim MS, Twaij H, Giebaly DE, Nizam I, Haddad FS. Enhanced recovery in total hip replacement: a clinical review. Bone Joint J. 2013 Dec;95-B(12):1587-94. doi: 10.1302/0301-620X.95B12.31303.

  • Liang C, Wei J, Cai X, Lin W, Fan Y, Yang F. Efficacy and Safety of 3 Different Anesthesia Techniques Used in Total Hip Arthroplasty. Med Sci Monit. 2017 Aug 2;23:3752-3759. doi: 10.12659/msm.902768.

  • Kearns RJ, Macfarlane AJ, Anderson KJ, Kinsella J. Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial. Trials. 2011 Feb 21;12:51. doi: 10.1186/1745-6215-12-51.

  • Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.

  • 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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joaquim Vieira

    Faculdade de Medicina da Universidade de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 18, 2019

Study Start

June 1, 2019

Primary Completion

November 4, 2019

Study Completion

November 1, 2020

Last Updated

January 5, 2021

Record last verified: 2019-10

Locations