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

NCT ID: NCT05056038

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lateral Quadratus Lumborum Block

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. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bıçakçılar Cooperation, Istanbul, Turkey) according to age and body weight.

Group Type ACTIVE_COMPARATOR

Lateral Quadratus Lumborum block

Intervention Type 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

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. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the posterior border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bıçakçılar Cooperation, Istanbul, Turkey) according to age and body weight.

Group Type ACTIVE_COMPARATOR

Posterior Quadratus Lumborum Block

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lateral Quadratus Lumborum block

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.

Intervention Type PROCEDURE

Posterior Quadratus Lumborum Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ozgecan Piril Zanbak

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayşe Çiğdem Tütüncü, Prof.

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University - Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Blanco R, McDonnell JG. Optimal point of injection: The quadratus lumborum type I and II blocks. Anaesthesia. 2013;68:4.

Reference Type BACKGROUND

Blanco R. Tap block under ultrasound guidance: the description of a "no pops" technique. Reg Anesth Pain Med. 2007;32:130.

Reference Type BACKGROUND

Zanbak Mutlu OP, Kendigelen P, Tutuncu AC. Lateral versus posterior quadratus lumborum block in children undergoing open orchiopexy: a double-blind randomized clinical trial. Braz J Anesthesiol. 2025 Jul 5;75(6):844661. doi: 10.1016/j.bjane.2025.844661. Online ahead of print.

Reference Type DERIVED
PMID: 40623532 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

90211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ESPB and ACB in Knee Arthroplasty
NCT05613101 COMPLETED NA