Clinical trial NCT05056038: Lateral Versus Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy
Official title: The Comparison of Ultrasound-Guided Lateral and Posterior Quadratus Lumborum Block in The Pediatric Patients Undergoing Orchiopexy. A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: quadratus lumborum block
pediatric patient
orchiopexy
pain
regional anesthesia
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 103
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* Undergoing elective unilateral orchiopexy

Exclusion Criteria:

* Not giving a consent
* Regional anesthesia contraindications
* ASA physical status IV
* Need to postoperative ICU care
* Laparoscopic orchiopexy

Primary outcomes:
measure: The Effect on Perioperative and Postoperative Pain
timeFrame: 24 hour
measure: Perioperative and Postoperative Total Analgesia Consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Parent satisfaction score
timeFrame: 24 hour
measure: Complications
timeFrame: 24 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Çiğdem Tütüncü, Prof.
role: STUDY_CHAIR
References:
citation: Blanco R, McDonnell JG. Optimal point of injection: The quadratus lumborum type I and II blocks. Anaesthesia. 2013;68:4.
citation: Blanco R. Tap block under ultrasound guidance: the description of a "no pops" technique. Reg Anesth Pain Med. 2007;32:130.