Clinical Trials Directory

Trials / Completed

CompletedNCT05056038

Lateral Versus Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy

The Comparison of Ultrasound-Guided Lateral and Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy. A Double Blind Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
103 (actual)
Sponsor
Istanbul University - Cerrahpasa · Academic / Other
Sex
Male
Age
6 Months – 12 Years
Healthy volunteers
Not accepted

Summary

There is a complex innervation of the testis and spermatic canal, and many different regional analgesia methods can be used for pain occurring during and after undescended testicular surgery. Quadratus lumborum block (QLB) can be count as the one of the primary method to manage the pain. In this study, our primary aim will be to compare the effects of lateral and posterior QLB application on perioperative and postoperative pain and analgesic use in pediatric patients who will undergo unilateral elective undescended testicular surgery. Our secondary aim will be to compare patient and family satisfaction and complications.

Detailed description

American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 6 month-12 years old children undergoing unilateral elective orchiopexy with general anesthesia will be recruited, after the informed consent will be obtained from the parents of the patients, in this triple blind randomized controlled trial. After the premedication with ketamine and midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane. Subsequently, before the surgery, the patients will be randomized and separated into 2 groups. The investigators will apply the lateral QLB to the first group and posterior QLB to the other group. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both group. In the peroperative period, if the additional analgesia will necessary, remifentanyl 0.1mcg/kg/min will be started, and dosage will be adjusted according to heart rate and blood pressure. If the blood pressure or heart rate will increase more than 20% from the preoperative basal value will be defined as the need for the analgesia. In the postoperative period, all cohort will be assessed by a blinded investigator at the 10,20,30th minutes, 1,2nd hours in the recovery room, 6th hour in the surgical ward, Face, Legs, Activity, Cry, Consolability Scale (FLACC) will be used for the pain evaluation. 16th and 24th hours will be monitored by the telephone visit from the parents, the pain will be evaluated with the Wong-Baker Faces Pain Rating Scale due to the same-day surgery concept.

Conditions

Interventions

TypeNameDescription
PROCEDURELateral Quadratus Lumborum blockLocal anesthetic may spread to the T6-L1 spinal nerves and paravertebral area by spreading through the lateral QLB to the transversus abdominis plane, and posteriorly via the anterior thoracolumbar fascia.
PROCEDUREPosterior Quadratus Lumborum BlockIn posterior QLB, the local anesthetic can spread on the anterior and lateral cutaneous branches of T4-L1 spinal nerves by administration of the agent to the lateral interfascial triangle.

Timeline

Start date
2021-07-01
Primary completion
2022-07-30
Completion
2022-07-30
First posted
2021-09-24
Last updated
2023-10-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05056038. Inclusion in this directory is not an endorsement.

Lateral Versus Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy (NCT05056038) · Clinical Trials Directory