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NCT Number: NCT07602894

Analgesia for Perineal Surgeries in High-risk Pediatric Patients

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy 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. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Systemic analgesia

Other

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.

Sacral multifidus plane block

Procedure

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

Primary outcomes

  1. Time to rescue analgesia

    Time frame: 24 hours

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

Secondary outcomes

  1. Heart rate

    Time frame: 24 hours

    The perioperative changes in heart rate basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.

  2. Mean arterial pressure

    Time frame: 24 hours

    The perioperative changes in mean blood pressure basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative.

  3. Postoperative pain score

    Time frame: 24 hours

    Pain score will be assessed using the Face, Legs, Activity, Cry, and Consolability score immediately postoperative then at 2, 4, 8, 16 and 24 hours with a score of 0 indicates no pain and 10 indicates maximum pain.

  4. Total dose of opioid consumption

    Time frame: 24 hours

    The total dose of opioid consumption as rescue analgesia in the first 24 hours postoperative.

  5. Parental satisfaction

    Time frame: 24 hours

    Parental satisfaction will be evaluated using a five-point score at the end of the first 24 hours with a score of 5 indicate the highest satisfaction and 1 indicate the lowest satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdalla Mohamed Goda Mohamed, MD

CONTACT

[email protected]

1114166085 ext. +20

Amira Attia Ebrahim Farag, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Efficacy of Ultrasound-guided Sacral Multifidus Plane Block as Perioperative Analgesia for Anal and Penile Surgeries in High-risk Pediatric Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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