PreemptiveNCT07853339
Preemptive and Postoperative Timing of Real-Time Sonar Guided Caudal Anesthesia for Pediatric Infra-Umbilical Procedures Analgesia
A study testing Caudal block immediately following induction of general anesthesia and Caudal block at the end of surgery in people with Preemptive and Postoperative Timing, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Preemptive, Postoperative Timing, Real-Time
- What is being tested?
- Caudal block immediately following induction of general anesthesia and Caudal block at the end of surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Preemptive and Postoperative Timing of Real-Time Sonar Guided Caudal Anesthesia for Pediatric Infra-Umbilical Procedures Analgesia: A Randamized Trial
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.
Read the 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.
- Conditions
- Preemptive, Postoperative Timing, Real-Time, Sonar, Caudal Anesthesia, Pediatric Infra-Umbilical Procedures
- Being tested
- Caudal block immediately following induction of general anesthesia, Caudal block at the end of surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal block immediately following induction of general anesthesiaDrug
Also called 0.25% bupivacaine
Patients will receive the caudal block immediately following induction of general anesthesia.
Caudal block at the end of surgeryDrug
Also called 0.25% bupivacaine
Patients will receive the caudal block at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Preemptive) | Experimental | Patients will receive the caudal block immediately following induction of general anesthesia. Receives: Drug: Caudal block immediately following induction of general anesthesia |
| Group II (Postoperative) | Experimental | Patients will receive the caudal block at the end of surgery. Receives: Drug: Caudal block at the end of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Total consumption of rescue analgesics
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.
Measured: 24 hours postoperatively
Heart rate
Heart rate was documented at the time of induction, at the moment of skin incision, and at 10-minute intervals throughout the surgical procedure.
Measured: Till the end of surgery (Up to 2 hours)
Mean arterial blood pressure
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.
Measured: Till the end of surgery (Up to 2 hours)
Peripheral oxygen saturation
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.
Measured: Till the end of surgery (Up to 2 hours)
End-Tidal Carbon Dioxide
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.
Measured: Till the end of surgery (Up to 2 hours)
Incidence of adverse events
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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreemptiveStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sharara, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853339
- Sponsor's protocol ID
- RC 3-5-2026
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Preemptive and Postoperative Timing of Real-Time Sonar Guided Caudal Anesthesia for Pediatric Infra-Umbilical Procedures Analgesia: A Randamized Trial
- ClinicalTrials.gov ID
- NCT07853339
- Acronym / sponsor ID
- RC 3-5-2026
- Conditions
- Preemptive, Postoperative Timing, Real-Time, Sonar, Caudal Anesthesia, Pediatric Infra-Umbilical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Preemptive) | Experimental | Drug: Caudal block immediately following induction of general anesthesiaPatients will receive the caudal block immediately following induction of general anesthesia. |
| Group II (Postoperative) | Experimental | Drug: Caudal block at the end of surgeryPatients will receive the caudal block at the end of surgery. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal block immediately following induction of general anesthesiaAlso: 0.25% bupivacainePatients will receive the caudal block immediately following induction of general anesthesia. | Drug | Group I (Preemptive) |
| Caudal block at the end of surgeryAlso: 0.25% bupivacainePatients will receive the caudal block at the end of surgery. | Drug | Group II (Postoperative) |
Primary outcome
Duration of effective postoperative analgesia
Time frame: 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.
6 secondary outcomes
Total consumption of rescue analgesics
Time frame: 24 hours postoperatively
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial blood pressure
Time frame: Till the end of surgery (Up to 2 hours)
Peripheral oxygen saturation
Time frame: Till the end of surgery (Up to 2 hours)
End-Tidal Carbon Dioxide
Time frame: Till the end of surgery (Up to 2 hours)
Incidence of adverse events
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal block immediately following induction of general anesthesia and Caudal block at the end of surgery in people with Preemptive and Postoperative Timing, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of effective postoperative analgesia (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.