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Clinical Trials/NCT04031196
NCT04031196
Completed
Not Applicable

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

Zagazig University1 site in 1 country34 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children
Sponsor
Zagazig University
Enrollment
34
Locations
1
Primary Endpoint
changes in intraoperative mean arterial blood pressure (MAP) values
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
July 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shereen Elsayed Abd Ellatif

lecturer of anesthesia and surgical intensive care

Zagazig University

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,
  • liver disease,
  • peritonitis,
  • and emergency cases

Outcomes

Primary Outcomes

changes in intraoperative mean arterial blood pressure (MAP) values

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)

(mm Hg)

changes in intraoperative heart rate (HR) values

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)

(beats/minute)

changes in the degree of pain perception by patient

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

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 Outcomes

  • post operative nausea and vomiting(in the first postoperative 24 hours)
  • total intraoperative fentanyl consumption(during the time of the surgical procedure)
  • 1st time of rescue analgesics(during the first postoperative 24 hours)
  • total amount of rescue analgesic consumed(in the first postoperative 24 hours)
  • degree of patient and parent satisfaction(at the end of the first postoperative 24 hours)

Study Sites (1)

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