Clinical trial NCT04031196: 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
Overall status: COMPLETED
Phase: NA
Conditions: Children
Appendicitis
Keywords: Pediatric
Quadratus Lumborum
regional anesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-07-24
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: changes in intraoperative mean arterial blood pressure (MAP) values
timeFrame: 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)
measure: changes in intraoperative heart rate (HR) values
timeFrame: 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)
measure: changes in the degree of pain perception by patient
timeFrame: 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 outcomes:
measure: total intraoperative fentanyl consumption
timeFrame: during the time of the surgical procedure
measure: 1st time of rescue analgesics
timeFrame: during the first postoperative 24 hours
measure: total amount of rescue analgesic consumed
timeFrame: in the first postoperative 24 hours
measure: post operative nausea and vomiting
timeFrame: in the first postoperative 24 hours
measure: degree of patient and parent satisfaction
timeFrame: at the end of the first postoperative 24 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, zagazig university
state: Elsharqya
Study officials:
affiliation: Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
name: Shereen E Abd Ellatif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University
name: Fatma M Ahmed, MD
role: STUDY_DIRECTOR
References:
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