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

Not Applicable

Completed

• Conditions: Appendicitis; Children

• Registration Number: NCT04031196
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-07-01
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
changes in intraoperative mean arterial blood pressure (MAP) values	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)	(mm Hg)
changes in intraoperative heart rate (HR) values	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)	(beats/minute)
changes in the degree of pain perception by patient	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	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

Name	Time	Method
post operative nausea and vomiting	in the first postoperative 24 hours	by number of patients complained of these side effects
1st time of rescue analgesics	during the first postoperative 24 hours	minute
degree of patient and parent satisfaction	at the end of the first postoperative 24 hours	5-point scale assessment (satisfied or completely satisfied, not satisfied nor dissatisfied, dissatisfied, completely dissatisfied)
total intraoperative fentanyl consumption	during the time of the surgical procedure	measured by μg /kg
total amount of rescue analgesic consumed	in the first postoperative 24 hours	mg/kg

Trial Locations

Locations (1)

Faculty of medicine, zagazig university; 🇪🇬 Zagazig, Elsharqya, Egypt