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Comparison of Caudal and Quadratus Lumborum Blocks With Pain Monitoring in Children

NCT07398573 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2026-02-10

No results posted yet for this study

Summary

Study Type: Prospective, Randomized, Observational Clinical Study

Primary Purpose:

The primary objective of this study is to compare the analgesic efficacy of caudal block (CB) and quadratus lumborum block (QLB) in children undergoing lower abdominal surgery using objective pain monitoring methods.

Key Questions Addressed:

Does the quadratus lumborum block provide superior intraoperative and postoperative analgesia compared to the caudal block, as measured by the Pain Monitor (PAM) and the FLACC scale?

Is the PAM monitor a reliable tool for objectively assessing nociception and pain in children who are unable to verbally express pain?

Which regional anesthesia technique more effectively delays the time to first postoperative analgesic requirement and reduces total analgesic consumption?

Which method is associated with higher parental satisfaction and fewer postoperative side effects, such as postoperative nausea and vomiting?

Comparison Groups:

Children receiving ultrasound-guided quadratus lumborum block will be compared with those receiving caudal block.

Intervention Group:

Bilateral quadratus lumborum block with 0.5 mL/kg of 0.25% bupivacaine.

Active Comparator Group:

Caudal block with 1 mL/kg of 0.125% bupivacaine.

Participant Population:

A total of 68 children, aged 2 months to 6 years, with ASA physical status I-II, scheduled for elective lower abdominal surgeries (e.g., inguinal hernia repair, orchiopexy, hydrocele).

What Participants Will Do:

Participants will receive the assigned regional block as part of standard anesthetic care. Observational data will be collected as follows:

Intraoperative: Continuous nociception monitoring using the PAM device at predefined time points (during laryngeal mask airway insertion, block performance, surgical incision, 20 minutes after block performance, and extubation).

Postoperative: Pain assessment using the FLACC scale at 1, 2, and 4 hours in the post-anesthesia care unit.

Rescue analgesia (intravenous paracetamol) will be administered if the FLACC score is ≥4. Time to first analgesic administration and total analgesic consumption will be recorded.

Additional outcomes include postoperative nausea and vomiting (PONV) scores, Steward recovery scores, and parental satisfaction scores assessed using the Pediatric Parental Satisfaction Scale (PPPS).

Primary Outcome:

Intraoperative PAM index scores.

Secondary Outcomes:

Postoperative FLACC scores, time to first analgesic requirement, total postoperative analgesic consumption, incidence and severity of PONV, Steward recovery scores, and parental satisfaction (PPPS) scores.

Conditions

  • Regional Anesthesia Success
  • Pain Monitor During Anesthesia
  • Quadratus Lumborum Nerve Block
  • Caudal Block for Postoperative Analgesia
  • Pediatric Anesthesia

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Principal Investigators

  • ASLI DONMEZ, Professor · Etlik City Hospital Health Science University

Eligibility

Min Age
2 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2026-02-02
Completion
2026-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398573 on ClinicalTrials.gov