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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03545295
Other study ID # Quadratus Lumborum Block
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial 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.


Description:

After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.


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 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

Exclusion Criteria:

- Previous spinal surgery.

- Significant spinal deformity

- Body mass index (BMI) = 35 kg / m2

- Absence of relatives or guardians who can sign the written consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Quadratus Lumborum Block type 2
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
Quadratus Lumborum Block type 3
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle

Locations

Country Name City State
Brazil Irmandade de Misericórdia da Santa Casa De São Paulo Sao 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 (17)

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. — View Citation

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. — View Citation

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. Erratum in: Reg Anesth Pain Med. 2018;43:111. — View Citation

Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Børglum 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Öksüz G, Bilal B, Gürkan Y, Urfalioglu A, Arslan M, Gisi G, Öksüz 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. — View Citation

Scimia P, Basso Ricci E, Petrucci E, Behr AU, Marinangeli F, Fusco P. Ultrasound-Guided Transversalis Fascia Plane Block: An Alternative Approach for Anesthesia in Inguinal Herniorrhaphy: A Case Report. A A Case Rep. 2017 Nov 1. doi: 10.1213/XAA.0000000000000666. [Epub ahead of print] — View Citation

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. — View Citation

Ueshima H, Hiroshi O. 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. — View Citation

Ueshima H, Otake H. 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. — View Citation

Ueshima H, Otake H. 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. — View Citation

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. Review. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Spread of coloring solution to the paravertebral space Observation of coloring solution on the paravertebral space. Comparison of spread to the paravertebral space according to the volume injected. 3 hours
Secondary Comparison of spread of the coloring solution between QLB 2 and QLB3 Observation of coloring solution around the spinal nerves as they exit the vertebral foramen and spread to the paravertebral space. Comparison of number of spinal nerves colored according to the technique used. 3 hours
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