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

NCT07853339 | Completed

• 1 other identifier: RC 3-5-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preemptive; Postoperative Timing; Real-Time; Sonar; Caudal Anesthesia; Pediatric Infra-Umbilical Procedures; Analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of effective postoperative analgesia

  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.

  24 hours postoperatively

Secondary Outcomes (6)

• Total consumption of rescue analgesics

  24 hours postoperatively

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Mean arterial blood pressure

  Till the end of surgery (Up to 2 hours)

• Peripheral oxygen saturation

  Till the end of surgery (Up to 2 hours)

• End-Tidal Carbon Dioxide

  Till the end of surgery (Up to 2 hours)

Study Arms (2)

Group I (Preemptive)

EXPERIMENTAL

Patients will receive the caudal block immediately following induction of general anesthesia.

Drug: Caudal block immediately following induction of general anesthesia

Group II (Postoperative)

EXPERIMENTAL

Patients will receive the caudal block at the end of surgery.

Drug: Caudal block at the end of surgery

Interventions

Caudal block immediately following induction of general anesthesia DRUG

Patients will receive the caudal block immediately following induction of general anesthesia.

Also known as: 0.25% bupivacaine

Group I (Preemptive)

Caudal block at the end of surgery DRUG

Patients will receive the caudal block at the end of surgery.

Also known as: 0.25% bupivacaine

Group II (Postoperative)

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13518, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Benha University, Egypt.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: June 1, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)