NCT07853586

Brief Summary

To compare the postoperative analgesic efficacy of ultrasound-guided Quadratus Lumborum Block (anterior approach) versus Erector Spinae Plane Block (T10-T12 level), both performed bilaterally with 0.25% bupivacaine (0.5 mL/kg per side), in the first 24 hours postoperatively in children undergoing elective open lower abdominal surgery under general anesthesia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

September 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

October 2, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

September 26, 2026

Last Update Submit

September 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time of first analgesic request

    in the first 24 hours

Secondary Outcomes (2)

  • total opioid (fentanyl equivalent) consumption /ug

    the first 24 hours postoperatively

  • postoperative pain intensity using the FLACC Scale (Face, Legs, Activity, Cry, Consolability)

    0, 30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively.

Study Arms (2)

Ultrasound guided anterior quadratus lumborum block

ACTIVE COMPARATOR
Procedure: ultrasound guided anterior oudratus lumborum block

ultrasound guided erector spinae block

ACTIVE COMPARATOR
Procedure: Ultrasound guided erector spinae plane block

Interventions

A high-frequency linear probe will be used to visualize the structures and a 22G, 80-mm echogenic needle will be inserted to deposit the drug. The probe will be placed above the iliac crest, and Petit's triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique, and transversus abdominus muscles) will be identified and will follow posteriorly until the layers of the Thoracolumbar Fascia (TLF) appeared as a bright hyper-echogenic line. The needle will be inserted in-plane along the posterior edge of the probe in anteromedial direction targeting the plane between the quadratus lumborum and psoas major muscle. After confirming the correct needle tip position and negative aspiration for blood, 0.5 mL/kg of 0.25% bupivacaine will be injected incrementally under real-time ultrasound guidance. The procedure will be repeated on the contralateral side.

Ultrasound guided anterior quadratus lumborum block

The patient will be placed in the prone or lateral decubitus position. The ultrasound probe will be positioned para-sagittally approximately 2-3 cm lateral to the midline at the T10-T12 vertebral level. The T11 transverse process will be identified deep to the erector spinae muscle complex. Using an in-plane caudal-to-cranial approach, a 22-gauge echogenic needle will be advanced until the tip contacts the transverse process. Following confirmation of correct plane by injection of 0.5-1 mL saline creating hydrodissection between the erector spinae and transverse process, 0.5 mL/kg of 0.25% bupivacaine will be injected incrementally. The procedure will be repeated contralaterally \].

ultrasound guided erector spinae block

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 2 to 7 years.
  • ASA Physical Status Classification I or II .
  • Scheduled for elective minor open lower abdominal surgery (bilateral inguinal hernia repair, orchiopexy, circumcision, bilateral hydrocele repair), pyeloplasty and ureteric reimplantation.
  • Weight between 10 and 25 kg.

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics (amide class).
  • Contraindications to regional anesthesia: coagulopathy (INR \> 1.5, platelets \< 80,000/mm³), local infection at the injection site, or raised intracranial pressure.
  • Pre-existing neurological, neuromuscular, or spinal disorders.
  • Significant hepatic dysfunction (Child-Pugh Class B or C) or severe renal impairment (eGFR \< 30 mL/min/1.73 m²).
  • Previous abdominal or retroperitoneal surgery which likely to distort fascial planes at the injection site.
  • Emergency or redo surgical procedures.
  • Inability to assess postoperative pain due to pre-existing developmental or cognitive impairment preventing validated pain scale use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Alexandria, Egypt

RECRUITING

Central Study Contacts

Nevine Soliman, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-07

Locations