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

Primary Purpose

Children, Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
QLB
TAP block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Children focused on measuring Pediatric, Quadratus Lumborum, regional anesthesia

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of medicine, zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

QLB group, Quadratus Lumborum Block group

TAP block group,Transversus Abdominis Plane Block group

Arm Description

the patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally.

patient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle,

Outcomes

Primary Outcome Measures

changes in intraoperative mean arterial blood pressure (MAP) values
(mm Hg)
changes in intraoperative heart rate (HR) values
(beats/minute)
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).

Secondary Outcome Measures

total intraoperative fentanyl consumption
measured by μg /kg
1st time of rescue analgesics
minute
total amount of rescue analgesic consumed
mg/kg
post operative nausea and vomiting
by number of patients complained of these side effects
degree of patient and parent satisfaction
5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)

Full Information

First Posted
July 17, 2019
Last Updated
August 5, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04031196
Brief Title
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy
Official Title
Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy: A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Appendicitis
Keywords
Pediatric, Quadratus Lumborum, regional anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients.
Masking
ParticipantCare Provider
Masking Description
the participants were masked for the type of regional anesthesia given the care provider was blind to the type of the regional block given to the patient and he was asked to assess the visual analogue scale score, first time of rescue analgesia, the total dose of rescue analgesia given and postoperative side effects.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QLB group, Quadratus Lumborum Block group
Arm Type
Active Comparator
Arm Description
the patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally.
Arm Title
TAP block group,Transversus Abdominis Plane Block group
Arm Type
Active Comparator
Arm Description
patient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle,
Intervention Type
Procedure
Intervention Name(s)
QLB
Intervention Description
QLB type 2 approach
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
classic TAP block approach
Primary Outcome Measure Information:
Title
changes in intraoperative mean arterial blood pressure (MAP) values
Description
(mm Hg)
Time Frame
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)
Title
changes in intraoperative heart rate (HR) values
Description
(beats/minute)
Time Frame
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)
Title
changes in the degree of pain perception by patient
Description
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).
Time Frame
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 Outcome Measure Information:
Title
total intraoperative fentanyl consumption
Description
measured by μg /kg
Time Frame
during the time of the surgical procedure
Title
1st time of rescue analgesics
Description
minute
Time Frame
during the first postoperative 24 hours
Title
total amount of rescue analgesic consumed
Description
mg/kg
Time Frame
in the first postoperative 24 hours
Title
post operative nausea and vomiting
Description
by number of patients complained of these side effects
Time Frame
in the first postoperative 24 hours
Title
degree of patient and parent satisfaction
Description
5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)
Time Frame
at the end of the first postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen E Abd Ellatif, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma M Ahmed, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, zagazig university
City
Zagazig
State/Province
Elsharqya
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the IPD that underlie results in a publication
IPD Sharing Time Frame
the IPD and any additional supporting information will become available starting 6 months after publication
IPD Sharing Access Criteria
by contacting the study director
Citations:
PubMed Identifier
23860059
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.
Results Reference
background
PubMed Identifier
21467560
Citation
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.
Results Reference
background
PubMed Identifier
21296242
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.
Results Reference
background
PubMed Identifier
24249997
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.
Results Reference
background
PubMed Identifier
27056207
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.
Results Reference
background
PubMed Identifier
27939905
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. No abstract available.
Results Reference
background
PubMed Identifier
23927552
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.
Results Reference
background
PubMed Identifier
27755488
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. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
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Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy

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