Health Trials

Analgesia for Perineal Surgeries in High-risk Pediatric Patients

ConditionAnalgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-12
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.

Pre-existing neurological disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systemic analgesia

    Other intervention

    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/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sacral Multifidus plane block groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

Heart rate

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.

Time frame
24 hours
2

Mean arterial pressure

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.

Time frame
24 hours
3

Postoperative pain score

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.

Time frame
24 hours
4

Total dose of opioid consumption

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

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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