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

NCT07398573 | Not Yet Recruiting

• 1 other identifier: AESH-EK-2025-225 03/09/2025
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Anesthesia; Regional Block; Pain Monitoring

Outcome Measures

Primary Outcomes (1)

• Intraoperative Pain Index Scores Measured by MEDSTORM Pain Monitor (PAM)

  The intraoperative analgesic efficacy of Caudal Block and Quadratus Lumborum (QL) Block will be assessed using the MEDSTORM Pain Monitor (PAM). The PAM provides a Pain Index score ranging from 0 to 10, reflecting the patient's nociceptive state and the need for analgesic intervention. Lower scores indicate better analgesic efficacy. Pain Index scores will be recorded at predefined perioperative time points. It is hypothesized that the QL block will result in lower intraoperative Pain Index scores compared to the caudal block. Pain Index interpretation: 0-1: No additional analgesia required 2-3: Additional analgesia may be required 4-5: Additional analgesia is likely required 6-7: Additional analgesia is probably needed 8-10: Additional analgesia is required Perioperative period, at the following predefined time points: At airway instrumentation During regional block performance At skin incision 20 minutes after block performance At emergence from anesthesia

  Perioperative period, at the following predefined time points: At airway instrumentation (laryngeal mask airway insertion) During regional block performance At skin incision 20 minutes after block performance At emergence from anesthesia (extubation)

Secondary Outcomes (7)

• Postoperative Pain Intensity Measured by FLACC Scale

  Postoperative period, assessed at: 1 hour after surgery 2 hours after surgery 4 hours after surgery

• Time to First Postoperative Analgesic Requirement

  Postoperative period, up to 4 hours after surgery

• Number of Participants Requiring Postoperative Rescue Analgesia

  Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery

• Total Postoperative Paracetamol Dose Administered

  Time Frame Postoperative period, up to 4 hours after surgery

• Adverse Effects, Postoperative Nausea and Vomiting (PONV) Severity Score

  Postoperative period, assessed at: 1 hour 2 hours 4 hours after surgery

Study Arms (2)

QUADRATUS LUMBORUM BLOCK GROUP

Intraoperatively, under ultrasound guidance, bilateral QL block with 0.5 ml/kg of 0.25% bupivacaine (maximum volume 20 ml) will be performed.

CAUDAL BLOCK GROUP

Under ultrasound guidance, a caudal block with 1 ml/kg of 0.125% bupivacaine (maximum volume 20 ml) will be performed.

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 2 months to 6 years with ASA I-II status undergoing lower abdominal surgeries (e.g., inguinal hernia, orchiopexy, hydrocele) performed by the pediatric surgery unit at Etlik City Hospital will be included.

You may qualify if:

• Pediatric patients between 2 months and 6 years of age
• Pediatric patients undergoing lower abdominal surgery
• Family consent must be obtained
• No contraindications to block (infection at the block site), coagulopathy (INR \<1.4, platelets \>100,000), local anesthetic allergy)
• ASA I-II patients

You may not qualify if:

• Severe systemic disease (ASA ≥III)
• Infection at the block site
• Coagulopathy (INR \>1.4, platelets \<100,000)
• Local anesthetic allergy
• Parental refusal
• Children aged \<2 months or \>6 years

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, YENIMAHALLE, 06170, Turkey (Türkiye)

Location

Related Publications (3)

• Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.

  PMID: 30851499 BACKGROUND

• Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.

  PMID: 31047645 BACKGROUND

• Zhu Y, Wu J, Qu S, Jiang P, Bohara C, Li Y. The analgesic effects of quadratus lumborum block versus caudal block for pediatric patients undergoing abdominal surgery: a systematic review and meta-analysis. Front Pediatr. 2025 Feb 6;13:1492876. doi: 10.3389/fped.2025.1492876. eCollection 2025.

  PMID: 39981211 BACKGROUND

Related Links

• Quadratus lumborum block procedure guide

Study Officials

• ASLI DONMEZ, Professor

  Etlik City Hospital Health Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DILARA YIGIT, Resident

CONTACT

+905334719202; dilaraa3632@gmail.com

GULSEN KESKIN, Assoc.Prof.

CONTACT

+905334133524; drgulsenkeskin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: February 10, 2026
• Study Start: February 2, 2026
• Primary Completion: February 2, 2026
• Study Completion: April 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)