NCT03545295

Brief Summary

Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 12, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

May 12, 2018

Last Update Submit

May 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spread of coloring solution according to the volume injected

    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.

    3 hours

Secondary Outcomes (2)

  • Spread of coloring solution to the paravertebral space

    3 hours

  • Comparison of spread of the coloring solution between QLB 2 and QLB3

    3 hours

Study Arms (6)

QLB 2 10ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 10 ml coloring solution

Procedure: Quadratus Lumborum Block type 2

QLB 2 20ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 20 ml coloring solution

Procedure: Quadratus Lumborum Block type 2

QLB 2 30ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 30 ml coloring solution

Procedure: Quadratus Lumborum Block type 2

QLB 3 10ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 10 ml coloring solution

Procedure: Quadratus Lumborum Block type 3

QLB 3 20ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 20 ml coloring solution

Procedure: Quadratus Lumborum Block type 3

QLB 3 30ml

EXPERIMENTAL

The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 30 ml coloring solution

Procedure: Quadratus Lumborum Block type 3

Interventions

Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle

QLB 2 10mlQLB 2 20mlQLB 2 30ml

Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle

QLB 3 10mlQLB 3 20mlQLB 3 30ml

Eligibility Criteria

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

You may qualify if:

  • Fresh corpses - not subjected to a formaldehyde process or frozen for more than 24 hours
  • Age ≥ 18 years.
  • Free, informed and informed consent signed by relatives or guardians of the body.
  • Height\> 150 cm and \<190 cm

You may not qualify if:

  • Previous spinal surgery.
  • Significant spinal deformity
  • Body mass index (BMI) ≥ 35 kg / m2
  • Absence of relatives or guardians who can sign the written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade de Misericórdia da Santa Casa De São Paulo

São Paulo, São Paulo, 01221020, Brazil

Location

Related Publications (16)

  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

    PMID: 27755488BACKGROUND
  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

    PMID: 26225500BACKGROUND
  • Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.

    PMID: 26735154BACKGROUND
  • Tamura T, Kitamura K, Yokota S, Ito S, Shibata Y, Nishiwaki K. Spread of Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: A Volunteer Study. Reg Anesth Pain Med. 2018 May;43(4):372-377. doi: 10.1097/AAP.0000000000000735.

    PMID: 29389680BACKGROUND
  • Wahal C, Kumar A, Pyati S. Advances in regional anaesthesia: A review of current practice, newer techniques and outcomes. Indian J Anaesth. 2018 Feb;62(2):94-102. doi: 10.4103/ija.IJA_433_17.

    PMID: 29491513BACKGROUND
  • Elsharkawy H, El-Boghdadly K, Kolli S, Esa WAS, DeGrande S, Soliman LM, Drake RL. Injectate spread following anterior sub-costal and posterior approaches to the quadratus lumborum block: A comparative cadaveric study. Eur J Anaesthesiol. 2017 Sep;34(9):587-595. doi: 10.1097/EJA.0000000000000680.

    PMID: 28731927BACKGROUND
  • Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.

    PMID: 28277325BACKGROUND
  • Hernandez MA, Vecchione T, Boretsky K. Dermatomal spread following posterior transversus abdominis plane block in pediatric patients: our initial experience. Paediatr Anaesth. 2017 Mar;27(3):300-304. doi: 10.1111/pan.13034. Epub 2017 Jan 18.

    PMID: 28098413BACKGROUND
  • Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.

    PMID: 28759502BACKGROUND
  • Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.

    PMID: 28802593BACKGROUND
  • Ueshima H, Otake H. RETRACTED: Clinical experiences of unilateral anterior sub-costal quadratus lumborum block for a nephrectomy. J Clin Anesth. 2018 Feb;44:120. doi: 10.1016/j.jclinane.2017.11.031. Epub 2017 Nov 29. No abstract available.

    PMID: 29195100BACKGROUND
  • Ueshima H, Hiroshi O. RETRACTED: Lumbar vertebra surgery performed with a bilateral posterior quadratus lumborum block. J Clin Anesth. 2017 Sep;41:61. doi: 10.1016/j.jclinane.2017.06.012. Epub 2017 Jul 3. No abstract available.

    PMID: 28802611BACKGROUND
  • Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.

    PMID: 28609336BACKGROUND
  • Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.

    PMID: 19462494BACKGROUND
  • Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.

    PMID: 21148659BACKGROUND
  • Ueshima H, Otake H. RETRACTED: Lower limb amputations performed with anterior quadratus lumborum block and sciatic nerve block. J Clin Anesth. 2017 Feb;37:145. doi: 10.1016/j.jclinane.2016.12.026. Epub 2017 Jan 10. No abstract available.

    PMID: 28235508BACKGROUND

Study Officials

  • Marilia Tassinari Gonçalves Preza, MD

    Post Graduate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo V Perez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the cadavers will be randomized to receive the intervention (Quadratus Lumborum Block) by different techniques (QLB 2/ QLB3) and different volumes (10, 20, 30 ml)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médico Assistente

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

The research results will be published in indexed scientific journals, maintaining participants identity confidential

Locations