NCT07602894

Brief Summary

Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.

Trial Health

65
Monitor

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
17mo left

Started Jul 2026

Status
not yet 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

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 15, 2026

Last Update Submit

May 21, 2026

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Time to rescue analgesia

    First time of additional analgesia given when the child exhibit moderate to severe pain with pain score become ≥ 4.

    24 hours

Secondary Outcomes (5)

  • Heart rate

    24 hours

  • Mean arterial pressure

    24 hours

  • Postoperative pain score

    24 hours

  • Total dose of opioid consumption

    24 hours

  • Parental satisfaction

    24 hours

Study Arms (2)

Sacral Multifidus plane block group

ACTIVE COMPARATOR

The patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.

Procedure: Sacral multifidus plane block

Control group

PLACEBO COMPARATOR

The patients will receive systemic parenteral analgesia.

Other: Systemic analgesia

Interventions

Systemic analgesiaOTHER

Patients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia.

Control group
Sacral multifidus plane blockPROCEDURE

Patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.

Sacral Multifidus plane block group

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents or caregivers' acceptance.
  • High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV)
  • Body mass index equal to 5%: 85% of the same age and sex.

You may not qualify if:

  • Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.
  • Pre-existing neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17.

    PMID: 35431750BACKGROUND

  • Stamer UM, Bernhart K, Lehmann T, Setzer M, Stuber F, Komann M, Meissner W. 'Desire for more analgesic treatment': pain and patient-reported outcome after paediatric tonsillectomy and appendectomy. Br J Anaesth. 2021 Jun;126(6):1182-1191. doi: 10.1016/j.bja.2020.12.047. Epub 2021 Mar 5.

    PMID: 33685632BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdelrazek yousef, MD

    Department of Pediatric surgery, Zagazig University

    PRINCIPAL INVESTIGATOR

  • Mohamed Ismail Sabry, MD

    Department of Pediatric surgery, Zagazig University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdalla Mohamed Goda Mohamed, MD

CONTACT

1114166085drabdogoda@gmail.com

Amira Attia Ebrahim Farag, MD

CONTACT

Amiraattia86@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05