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Post Operative PainNCT06725862

Caudal Block vs Retrolaminar Block on Analgesic Consumption in Undescended Testis Surgeries

A study testing Retrolaminar Block (RLB) and Caudal Block (CB) in people with Post Operative Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study compares the postoperative analgesic effectiveness of Caudal Block (CB) and Retrolaminar Block (RLB) in pediatric patients undergoing undescended testis surgeries. Both techniques aim to manage pain effectively and reduce reliance on systemic analgesics, improving recovery and minimizing complications. Read more about this study

Who is it for?
Ages 1 year to 7 years, men only
Conditions the study is for
Post Operative Pain
What is being tested?
Retrolaminar Block (RLB) and Caudal Block (CB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Dec 2024to 16 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 7 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • Pediatric patients aged 1-7 years. ASA (American Society of Anesthesiologists) physical status I or II. Scheduled for unilateral undescended testis surgery. Parental/guardian consent provided for study participation.

Who cannot join

  • Age under 1 year or over 7 years. Neurological deficits. Coagulopathy or bleeding disorders. History of allergy to local anesthetics. Signs of redness, infection, or other abnormalities at the injection site. Congenital spinal anomalies. Intellectual disability or psychiatric disorders. Hepatic or renal impairment. Refusal to participate in the study by parents or guardians.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Engin ihsan Turan contact

05382431114

enginihsan@hotmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303

    Engin ihsan Turan, 05382431114, enginihsan@hotmail.com

    Recruiting
  • Zincirlikuyu Medicana Hospital

    Istanbul

    Selçuk Alver, Ass.Prof.Dr, +905435424234, selcukalver@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Caudal Block and Retrolaminar Block on Analgesic Consumption in Postoperative Pain Management for Pediatric Undescended Testis Surgeries

This study compares the postoperative analgesic effectiveness of Caudal Block (CB) and Retrolaminar Block (RLB) in pediatric patients undergoing undescended testis surgeries. Both techniques aim to manage pain effectively and reduce reliance on systemic analgesics, improving recovery and minimizing complications.

The double-blind, randomized controlled trial will include 1-7-year-old ASA I-II patients at two hospitals. Patients with specific contraindications (e.g., spinal anomalies, allergies, or infections) will be excluded. Randomization divides participants into two groups (CB and RLB), with pain assessments performed using the FLACC pain scale by a blinded nurse.

Read more

Procedures:

CB: 0.125% bupivacaine (1 mL/kg, max 20 mL) injected into the sacral canal under ultrasound guidance.

RLB: 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 level under ultrasound guidance.

Postoperative pain will be evaluated at various intervals (30 minutes to 24 hours). Intravenous paracetamol or tramadol will be administered based on pain scores.

The study aims to compare pain scores, time to first analgesic requirement, and postoperative complications, contributing valuable data on these two regional anesthesia techniques in pediatric surgery.

Read the detailed description

Pediatric lower abdominal surgeries, especially undescended testis surgeries, are procedures that can cause significant pain in the postoperative period. Effective pain management in such surgeries is crucial to accelerate recovery in children and reduce complications associated with analgesic medications. Among the most commonly used regional anesthesia techniques for pediatric lower abdominal surgeries is the caudal block, which has provided effective pain management for many years. However, in recent years, ultrasound-guided trunkal nerve blocks have gained popularity due to their targeted and prolonged analgesic effects. One such block, the retrolaminar block (RLB), is a relatively new technique applied around the spinal laminae with local anesthetics and has been increasingly utilized in pediatric surgeries.

While the caudal block is widely used in lower abdominal surgeries, ensuring proper distribution of the anesthetic agent and monitoring for potential side effects during the procedure is necessary. In contrast, the retrolaminar block, performed reliably under ultrasound guidance, is suggested to provide longer-lasting analgesia compared to the caudal block. The RLB allows for broader spread of the local anesthetic in the paraspinal region, potentially affecting both lower and upper areas. However, studies comparing the postoperative analgesic effects of RLB and caudal block in pediatric patients are quite limited in the literature.

This study aims to compare the postoperative analgesic effectiveness of caudal block and retrolaminar block in pediatric patients undergoing undescended testis surgeries. The study evaluates differences between these two regional anesthesia techniques in terms of postoperative pain scores, time to first analgesic requirement, and postoperative complications. The limited data available on these block methods in the literature highlight the potential scientific contribution of this study.

This double-blind, randomized controlled trial will be conducted at Prof. Dr. Cemil Taşçıoğlu City Hospital and Zincirlikuyu Medicana Hospitals. Following clinical ethics committee approval, the study will include pediatric patients aged 1 to 7 years who are classified as ASA I-II and scheduled for unilateral undescended testis surgeries.

Patients under 1 year or over 7 years, those with neurological deficits, bleeding disorders, a history of allergies to local anesthetics, signs of redness or infection at the injection site during physical examination, congenital spinal anomalies, mental retardation, psychiatric disorders, liver or kidney disease, and those who do not consent to participate will be excluded from the study.

Randomization and blinding Randomization will be performed using a computer-generated randomization table, dividing patients into two groups: Retrolaminar Block (RLB) and Caudal Block (CB). Pain evaluation will be conducted using the FLACC pain scale, assessed by a blinded nurse. The anesthesiologist will be blinded to data collection related to analgesic requirements and postoperative complications. Transparent sterile drapes will be applied to all injection sites to blind the anesthesiologist to postoperative outcomes.

General anesthesia procedure All patients will receive 0.5 mg/kg oral midazolam as premedication. Following standard monitoring in the operating room, general anesthesia will be induced with 2 mg/kg intravenous propofol and 0.5 μg/kg fentanyl. After loss of the eyelash reflex, a laryngeal mask airway suitable for the patient's age and weight will be inserted without using muscle relaxants, and the patient will be connected to the anesthesia machine. Anesthesia will be maintained with 2% sevoflurane in a 50% air-oxygen mixture. Demographic data (age, weight, duration of surgery) and complications will be recorded.

Regional anesthesia procedure Blocks will be performed in the left lateral decubitus position under ultrasound guidance by a single experienced operator after induction of general anesthesia and securing the airway. A 22-G insulated 50-mm sonographic needle will be used for all injections. Ultrasound guidance will be performed using a linear probe (6.5-18 MHz) in nerve imaging mode.

Caudal Block (CB) procedure The surgical area will be sterilized with povidone-iodine. The sacral hiatus will be visualized using the out-of-plane transverse imaging technique, and 0.125% bupivacaine at a dose of 1 mL/kg (maximum 20 mL) will be injected into the sacral canal.

Retrolaminar Block (RLB) procedure Patients will be positioned in the left lateral decubitus position. Using a paramedian sagittal approach at the L4 vertebral level, the transverse process of L4 will be located with the ultrasound probe. A needle will then be advanced into the retrolaminar space between the L4 lamina and paraspinal muscles, and 0.25% bupivacaine at a dose of 0.1 mL/kg will be injected.

Caudal block has long been used as a method of pain relief in pediatric anesthesia, significantly improving postoperative comfort, relieving pain, and reducing side effects such as nausea and vomiting. Similarly, retrolaminar block, which is among the routine practices in our hospital, enhances postoperative comfort by better controlling pain. This technique provides safe and effective analgesia by targeting nerves through injections into the lamina region of the spine while minimizing spread to surrounding tissues. The efficacy and reliability of retrolaminar block support its preference in postoperative pain management.

Postoperative follow-up and pain evaluation Pain will be assessed using the FLACC pain scale at 30 minutes, and at 1, 2, 4, 6, 12, and 24 hours. Patients with scores of 2-4 will receive intravenous paracetamol, and those with scores above 4 will be given intravenous tramadol. The timing and amount of analgesic use will be recorded.

Being tested
Retrolaminar Block (RLB), Caudal Block (CB)
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrolaminar Block (RLB)Procedure or surgery

    This intervention involves administering 0.25% bupivacaine (0.1 mL/kg) into the retrolaminar space at the L4 vertebral level using a 22-G insulated needle under ultrasound guidance in pediatric patients after induction of general anesthesia.

  • Caudal Block (CB)Procedure or surgery

    This intervention involves administering 0.125% bupivacaine (1 mL/kg, maximum 20 mL) into the sacral canal using a 22-G insulated needle under ultrasound guidance in pediatric patients after induction of general anesthesia.

Study groups in NCT06725862
Study groupRoleWhat they receive
Retrolaminar block groupExperimentalPediatric patients in this group will receive a retrolaminar block (RLB) using 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 vertebral level under ultrasound guidance after general anesthesia induction.
Receives: Procedure: Retrolaminar Block (RLB)
Caudal Block (CB) GroupActive comparatorPediatric patients in this group will receive a caudal block (CB) using 0.125% bupivacaine (1 mL/kg, maximum 20 mL) injected into the sacral canal under ultrasound guidance after general anesthesia induction.
Receives: Procedure: Caudal Block (CB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Scores

    Assessment of postoperative pain scores using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at predefined intervals (30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively). Scores range from 0 to 10, with higher scores indicating greater pain intensity.

    Measured: Up to 24 hours postoperatively.

Secondary outcomes (3)
  1. Time to First Analgesic Requirement

    The time elapsed from the completion of the surgical procedure to the first administration of rescue analgesia (IV paracetamol or tramadol) based on FLACC scores.

    Measured: Up to 24 hours postoperatively.

  2. Total Analgesic Consumption

    The cumulative amount of analgesic medications (paracetamol and/or tramadol) administered within the first 24 hours postoperatively.

    Measured: Up to 24 hours postoperatively.

  3. Incidence of Postoperative Complications

    The occurrence of complications such as nausea, vomiting, or urinary retention associated with the analgesic techniques used.

    Measured: Up to 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start15 Dec 2024
  3. Primary completion15 Dec 2025 (estimated)
  4. Study completion16 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725862
Sponsor's protocol ID
caudal vs retrolaminar
Status last verified
Feb 2025
First submitted
5 Dec 2024
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ozen V, Umutoglu T, Turan EI, Ayas TA, Yigit D, Ciftci B, Alver S. Comparison of caudal and retrolaminar blocks for postoperative analgesia in pediatric orchidopexy: a randomized controlled trial. Minerva Anestesiol. 2026 Jun;92(6):560-568. doi: 10.23736/S0375-9393.25.19579-5. Epub 2026 Mar 26.

    PubMed 41884978

Questions about this trial

What is this clinical trial studying?

A study testing Retrolaminar Block (RLB) and Caudal Block (CB) in people with Post Operative Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Engin ihsan Turan (05382431114, enginihsan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Scores (time frame: Up to 24 hours postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06725862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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