Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy

Children Clinical Trial

Official title:

Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031196
• Other study ID #: 5504-16-9-2018
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked.

Description:

Recently, the laparoscopic technique has been successfully used for many pediatric surgical cases. The laparoscopic appendicectomy is favored over the traditional open method, as it has a lower incidence of postoperative surgical complications and faster recovery to normal daily activities. Although it is considered as minimally invasive surgery, patients may require hospitalization for over 24 hours following laparoscopic appendicectomy, and postoperative pain which is caused by the surgical wound and visceroperitonitic pain as a result of peritoneal inflammation and infection, may extend the length of hospital stay.

Regional anesthesia techniques are commonly enhanced for pain management in pediatric surgical procedure as they decrease parenteral opioid requirements and improve patient-parent satisfaction [6].

The Transversus Abdominis Plane (TAP) block was first described in 2004 by McDonnell et al. using anatomical landmark guidance, and ultrasound-guided technique was later popularized by Hebbard et al. TAP block is aiming to block sensory nerves that course between the transversus abdominis and internal oblique muscles and supply the anterior abdominal wall, where local anesthetic is injected into the transversus abdominis fascial plane. Many clinical studies have reported the efficacy of TAP block in providing adequate postoperative analgesia for lower abdominal surgery.

Quadratus Lumborum block was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the local anesthetic (LA) was injected in the anterolateral aspect of the QL muscle (type 1 QL block). Later, J. Børglum used posterior transmuscular approach by detecting Shamrock sign and injecting the LA in the anterior aspect of the QL (type 3 QL block). Recently, R. Blanco described another approach by injecting the LA in the posterior aspect of the QL muscle (type 2 QL block), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is reduced. And finally the intramuscular QL block (type 4 QL block), the local anesthetic is injected directly into the QL muscle.

We hypothesize that ultrasound-guided QL block will be more superior than or equal to TAP block in providing postoperative analgesia for children undergoing laparoscopic appendicectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• parent and patient acceptance,

• Children 7-12 years old,

• 20-35kg bodyweight,

• ASA I-II,

• and scheduled for Laparoscopic appendicectomy

Exclusion Criteria:

• Patients refusing regional anesthesia,

• those with bleeding disorders,

• skin lesion at the needle insertion site,

• sepsis,

• liver disease,

• peritonitis,

• and emergency cases

Related Conditions & MeSH terms

• Appendicitis
• Children

Intervention

Procedure:
• QLB
QLB type 2 approach
• TAP block
classic TAP block approach

Locations

Country	Name	City	State
Egypt	Faculty of medicine, zagazig university	Zagazig	Elsharqya

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg. 2011 Jun;112(6):1504-8. doi: 10.1213/ANE.0b013e3182159bf8. Epub 2011 Apr 5. — 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

Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035. — View Citation

Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148. — View Citation

Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. — View Citation

Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008. Review. — View Citation

Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8. — View Citation

Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in intraoperative mean arterial blood pressure (MAP) values	(mm Hg)	at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
Primary	changes in intraoperative heart rate (HR) values	(beats/minute)	at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)
Primary	changes in the degree of pain perception by patient	measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).	Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia
Secondary	total intraoperative fentanyl consumption	measured by µg /kg	during the time of the surgical procedure
Secondary	1st time of rescue analgesics	minute	during the first postoperative 24 hours
Secondary	total amount of rescue analgesic consumed	mg/kg	in the first postoperative 24 hours
Secondary	post operative nausea and vomiting	by number of patients complained of these side effects	in the first postoperative 24 hours
Secondary	degree of patient and parent satisfaction	5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)	at the end of the first postoperative 24 hours