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NCT Number: NCT05056038

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpasa

Istanbul, 34100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lateral Quadratus Lumborum block

Procedure

Local 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.

Posterior Quadratus Lumborum Block

Procedure

In 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.

Primary outcomes

  1. The Effect on Perioperative and Postoperative Pain

    Time frame: 24 hour

    The Face Legs Activity Cry Consobility (FLACC) Score will be used in hospital. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned. For the evaluation of the post-discharge, Wong Baker Pain score will be used. According to Wong Baker Score Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.

  2. Perioperative and Postoperative Total Analgesia Consumption

    Time frame: 24 hour

    The perioperative necessity of the additional analgesia was determined as the 20% increase of the heart rate and blood pressure values from the basal level and the dose of the remifentanyl was adjusted according to this protocol. The Face Legs Activity Cry Consobility (FLACC) Score will be used in hospital. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned. For the evaluation of the post-discharge, Wong Baker Pain score will be used. According to Wong Baker Score Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.

Secondary outcomes

  1. Parent satisfaction score

    Time frame: 24 hour

    At the postoperative 24th hour, the investigator will ask to the parents by telephone visit. Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3).

  2. Complications

    Time frame: 24 hour

    The investigators will screen and record the complications such as nausea, vomiting, haematoma, solid organ injury, etc.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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