Preemptive and Postoperative Timing of Real-Time Sonar Guided Caudal Anesthesia for Pediatric Infra-Umbilical Procedures Analgesia

NCT07853339 — Not applicable, Completed, 100 participants, Benha University

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Comparing Preemptive and Postoperative Timing of Real-Time Sonar Guided Caudal Anesthesia for Pediatric Infra-Umbilical Procedures Analgesia: A Randamized Trial

RegistryNCT07853339
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment100 (Actual)
SponsorBenha University (Other)
ConditionsPreemptive, Postoperative Timing, Real-Time, Sonar, Caudal Anesthesia, Pediatric Infra-Umbilical Procedures, Analgesia
InterventionsCaudal block immediately following induction of general anesthesia, Caudal block at the end of surgery (Drug)
Datesstart 2026-06-01, primary completion 2026-09-01, completion 2026-09-01, first posted 2026-10-01, last updated 2026-10-01
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Preemptive All trials for Postoperative Timing All trials of Caudal block immediately following induction of general anesthesia All trials of Caudal block at the end of surgery

-Summary

This study compared preemptive and postoperative real-time ultrasound-guided caudal block with respect to analgesic efficacy, opioid consumption, and hemodynamic stability in children undergoing infra-umbilical procedures.

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+Detailed description

Adequate postoperative analgesia is essential for optimal recovery in children undergoing surgical procedures, yet it remains challenging due to their limited ability to self-report pain effectively.

Multimodal analgesia has become the standard approach to balance efficacy and safety in pediatric patients, incorporating non-opioid agents, regional techniques, and judicious use of opioids.

The caudal epidural block is a well-established and reliable regional anesthesia technique for providing both intra- and postoperative analgesia in pediatric patients undergoing infra-umbilical procedures.

The incorporation of real-time ultrasound (sonar) guidance has significantly enhanced the accuracy, safety, and success rate of caudal blocks by allowing direct visualization of anatomical structures, needle placement, and local anesthetic spread.

+Arms and interventions

ArmTypeInterventionsDescription
Group I (Preemptive)ExperimentalDrug: Caudal block immediately following induction of general anesthesiaPatients will receive the caudal block immediately following induction of general anesthesia.
Group II (Postoperative)ExperimentalDrug: Caudal block at the end of surgeryPatients will receive the caudal block at the end of surgery.
  • Caudal block immediately following induction of general anesthesia (Drug), also known as 0.25% bupivacaine: Patients will receive the caudal block immediately following induction of general anesthesia.
  • Caudal block at the end of surgery (Drug), also known as 0.25% bupivacaine: Patients will receive the caudal block at the end of surgery.

+Outcome measures

Primary outcomes

  • Duration of effective postoperative analgesia [24 hours postoperatively]: The total duration of effective postoperative analgesia, defined as the time elapsed from the end of surgery to the first FLACC score ≥4 necessitating rescue analgesia.

Secondary outcomes

  • Total consumption of rescue analgesics [24 hours postoperatively]: Rescue analgesia with intravenous fentanyl (0.5-1 μg/kg) was administered when FLACC scores reached or exceeded 4, with dosing governed by institutional protocol.
  • Heart rate [Till the end of surgery (Up to 2 hours)]: Heart rate was documented at the time of induction, at the moment of skin incision, and at 10-minute intervals throughout the surgical procedure.
  • Mean arterial blood pressure [Till the end of surgery (Up to 2 hours)]: Mean arterial blood pressure was documented at the time of induction, at the moment of skin incision, and at 10-minute intervals throughout the surgical procedure.
  • Peripheral oxygen saturation [Till the end of surgery (Up to 2 hours)]: Peripheral oxygen saturation was documented at the time of induction, at the moment of skin incision, and at 10-minute intervals throughout the surgical procedure.
  • End-Tidal Carbon Dioxide [Till the end of surgery (Up to 2 hours)]: End-Tidal Carbon Dioxide was documented at the time of induction, at the moment of skin incision, and at 10-minute intervals throughout the surgical procedure.
  • Incidence of adverse events [24 hours postoperatively]: Incidence of adverse events such as postoperative nausea and vomiting (PONV), hematoma, hypotension, urinary retention requiring urinary catheterization, respiratory depression, bradycardia, and local anesthetic systemic toxicity (LAST), was recorded.

+Eligibility

Sex: All, ages: 1 Year to 7 Years

Inclusion Criteria:

* Pediatric patients (aged 1-7 years).
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Scheduled for elective infra-umbilical surgical procedures, including inguinal hernia repair, orchidopexy, and hypospadias repair.

Exclusion Criteria:

* Parental refusal to provide written informed consent.
* Known sacral or spinal anatomical abnormalities (e.g., spina bifida).
* Infection at the proposed site of needle insertion.
* Coagulopathy or bleeding disorders.
* History of allergy to local anesthetic agents, including bupivacaine or ropivacaine.

+Locations (1)

FacilityCityCountryStatus
Benha UniversityBanhā, BenhaEgypt