Actively Recruiting

Phase Not Applicable
Age: 1Year - 7Years
MALE
ID06725862

Comparison of Caudal Block and Retrolaminar Block Effects on Postoperative Pain and Analgesic Use in Pediatric Undescended Testis Surgery

Led by Kanuni Sultan Suleyman Training and Research Hospital · Updated on 2025-02-18

60

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two regional anesthesia techniques, Caudal Block (CB) and Retrolaminar Block (RLB), for managing postoperative pain in children undergoing surgery for undescended testis. This study focuses on pediatric patients aged 1 to 7 years who are classified as ASA I-II and aims to compare pain scores, time to first analgesic use, and postoperative complications. The research is a double-blind, randomized controlled trial conducted at two hospitals. Participants will be randomly assigned to receive either the Caudal Block or the Retrolaminar Block after general anesthesia induction. The Caudal Block involves injecting 0.125% bupivacaine into the sacral canal, while the Retrolaminar Block uses 0.25% bupivacaine injected into the retrolaminar space at the L4 vertebral level, both performed under ultrasound guidance by an experienced operator. General anesthesia includes premedication with midazolam, induction with propofol and fentanyl, and maintenance with sevoflurane. During the 24-hour postoperative period, pain will be assessed at multiple timepoints using the FLACC pain scale by a blinded nurse. Patients with mild to moderate pain will receive intravenous paracetamol, while those with higher pain scores will be given intravenous tramadol. Researchers will monitor analgesic consumption, pain scores, and any complications. The study includes detailed follow-up assessments to provide valuable data on these two pain management techniques in pediatric surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 7Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged 1-7 years
  • ASA physical status I or II
  • Scheduled for unilateral undescended testis surgery
  • Parental or guardian consent provided
Not Eligible

You will not qualify if you...

  • Age under 1 year or over 7 years
  • Neurological deficits
  • Coagulopathy or bleeding disorders
  • Allergy to local anesthetics
  • Redness, infection, or abnormalities at injection site
  • Congenital spinal anomalies
  • Intellectual disability or psychiatric disorders
  • Liver or kidney disease
  • Refusal by parents or guardians to participate in the study
  • Female gender (implied by study population male only in screening question and criteria description, but not explicitly stated in exclusion; included here for clarity of participant gender restriction as per source data)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants undergo general anesthesia followed by either a retrolaminar block or a caudal block for pain management during undescended testis surgery.

1 visit (in-person, day of surgery)

Post-operative Follow-up

Duration - Up to 24 hours postoperatively

Participants are monitored for postoperative pain and analgesic use for 24 hours after surgery.

Multiple pain assessments at 30 minutes, 1, 2, 4, 6, 12, and 24 hours post-surgery

Trial Site Locations

Total: 2 locations

1

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Turkey (Türkiye), 34303

Actively Recruiting

2

Zincirlikuyu Medicana Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

E

Engin ihsan Turan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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