Caudal Epidural AnesthesiaNCT07426939
Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery
A study testing caudal block and Erector Spinae Plane Block in people with Caudal Epidural Anesthesia and Erector Spinae Plane Block, run by Ankara City Hospital Bilkent.
Trial summary
In routine pediatric surgical practice, lower abdominal surgeries are commonly performed. Inadequate control of postoperative pain can hinder functional recovery and may lead to negative behavioral changes as well as parental dissatisfaction. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caudal Epidural Anesthesia, Erector Spinae Plane Block, Pediatric
- What is being tested?
- caudal block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 1 to 8 years
- Scheduled for elective lower abdominal surgery
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from parent(s) or legal guardian(s)
Who cannot join
- Presence of anatomical abnormalities
- Coagulation disorders
- Infection at the site of block application
- Severe cardiovascular, neurological, respiratory, or metabolic disease
- Known allergy to study medications
- Failed regional block
- Bilateral surgery or additional surgical procedures involving different surgical sites
- Refusal of parent(s) or legal guardian(s) to provide consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In routine pediatric surgical practice, lower abdominal surgeries are commonly performed. Inadequate control of postoperative pain can hinder functional recovery and may lead to negative behavioral changes as well as parental dissatisfaction. Regional anesthesia techniques are widely recommended for pain management in pediatric surgery, as they reduce the need for parenteral opioids and improve the effectiveness of postoperative pain control, patient comfort, and parental satisfaction.
Various nerve block techniques have been developed to enhance postoperative analgesia and facilitate recovery in pediatric patients. However, there is still no consensus regarding the most effective regional anesthesia strategy for pediatric surgical procedures.
Read more
Among regional anesthesia techniques used for pain management in children undergoing lower abdominal surgery, caudal block remains the most commonly applied method. The introduction of real-time ultrasound guidance has improved the reliability and safety of caudal blocks. Nevertheless, a major limitation of this technique is its relatively short duration of action following a single injection, even when long-acting local anesthetics or adjuvant agents are used. Consequently, several fascial plane blocks, such as the quadratus lumborum block, transversus abdominis plane block, and rectus sheath block, have been proposed as alternative approaches for postoperative analgesia in children.
The erector spinae plane block is a regional anesthesia technique that has been applied at thoracic, lumbar, cervical, and sacral levels for both acute and chronic pain management. By providing blockade of both somatic and visceral pain pathways, it has demonstrated effective postoperative analgesic properties in a variety of thoracic and abdominal surgical procedures. The technique involves the injection of a local anesthetic into the interfascial plane between the erector spinae muscle and the transverse process, allowing longitudinal spread of the anesthetic across multiple spinal levels.
With a growing body of evidence supporting its feasibility and effectiveness, the erector spinae plane block has gained increasing attention in pediatric anesthesia practice.
The aim of this study is to evaluate and compare the analgesic efficacy and safety of ultrasound-guided erector spinae plane block and caudal block in pediatric patients undergoing unilateral lower abdominal surgery under general anesthesia. The primary objective is to compare postoperative pain levels between the two techniques using the FLACC score, which assesses facial expression, leg position, activity, crying, and consolability. Secondary objectives include the evaluation of intraoperative heart rate, blood pressure, and oxygen saturation, block application times, parental satisfaction, and the incidence of postoperative side effects.
- Being tested
- caudal block, Erector Spinae Plane Block
- Keywords
- espb, caudal block, pediatric, erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal blockProcedure or surgery
A single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique.
Erector Spinae Plane BlockProcedure or surgery
A single-shot ultrasound-guided erector spinae plane block will be performed at the L1 transverse process level using an in-plane technique.
| Study group | Role | What they receive |
|---|---|---|
| Caudal Block Group | Active comparator | Participants will receive an ultrasound-guided caudal epidural block with bupivacaine. Receives: Procedure: caudal block |
| Erector spinae plane block group | Active comparator | Participants will receive an ultrasound-guided erector spinae plane block with bupivacaine. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC pain score
Postoperative pain will be assessed using the FLACC scale. Unit of Measure: Score (0-10)
Measured: 0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery
Secondary outcomes (9)
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesic
Measured: Up to 24 hours postoperatively
Duration of Effective Analgesia
Time from block application to the first FLACC pain score ≥4
Measured: Up to 24 hours postoperatively
Duration of Anesthesia
Time from anesthesia induction to awake extubation
Measured: Intraoperative period
Duration of Surgery
Time from skin incision to skin closure
Measured: Intraoperative period
Block Performance Time
Time from needle insertion to completion of block procedure
Measured: Intraoperative period
Intraoperative Heart Rate
Heart rate measured intraoperatively
Measured: 0, 15, 30, 45 minutes and 1 hour after inductio
Intraoperative Mean Arterial Pressure
Mean arterial pressure measured intraoperatively
Measured: 0, 15, 30, 45 minutes and 1 hour after induction
Intraoperative Oxygen Saturation
Peripheral oxygen saturation measured intraoperatively
Measured: 0, 15, 30, 45 minutes and 1 hour after induction
Postoperative Adverse Events
Incidence of postoperative adverse events including nausea, vomiting, nerve injury, or infection
Measured: First 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 posted23 Feb 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeki D Kuvet, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426939
- Sponsor's protocol ID
- TABED 1-25-1436
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07426939
- Acronym / sponsor ID
- TABED 1-25-1436
- Keywords
- espb, caudal block, pediatric, erector spinae plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Feb 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.
In routine pediatric surgical practice, lower abdominal surgeries are commonly performed. Inadequate control of postoperative pain can hinder functional recovery and may lead to negative behavioral changes as well as parental dissatisfaction. Regional anesthesia techniques are widely recommended for pain management in pediatric surgery, as they reduce the need for parenteral opioids and improve the effectiveness of postoperative pain control, patient comfort, and parental satisfaction.
Various nerve block techniques have been developed to enhance postoperative analgesia and facilitate recovery in pediatric patients. However, there is still no consensus regarding the most effective regional anesthesia strategy for pediatric surgical procedures.
Among regional anesthesia techniques used for pain management in children undergoing lower abdominal surgery, caudal block remains the most commonly applied method. The introduction of real-time ultrasound guidance has improved the reliability and safety of caudal blocks. Nevertheless, a major limitation of this technique is its relatively short duration of action following a single injection, even when long-acting local anesthetics or adjuvant agents are used. Consequently, several fascial plane blocks, such as the quadratus lumborum block, transversus abdominis plane block, and rectus sheath block, have been proposed as alternative approaches for postoperative analgesia in children.
The erector spinae plane block is a regional anesthesia technique that has been applied at thoracic, lumbar, cervical, and sacral levels for both acute and chronic pain management. By providing blockade of both somatic and visceral pain pathways, it has demonstrated effective postoperative analgesic properties in a variety of thoracic and abdominal surgical procedures. The technique involves the injection of a local anesthetic into the interfascial plane between the erector spinae muscle and the transverse process, allowing longitudinal spread of the anesthetic across multiple spinal levels.
With a growing body of evidence supporting its feasibility and effectiveness, the erector spinae plane block has gained increasing attention in pediatric anesthesia practice.
The aim of this study is to evaluate and compare the analgesic efficacy and safety of ultrasound-guided erector spinae plane block and caudal block in pediatric patients undergoing unilateral lower abdominal surgery under general anesthesia. The primary objective is to compare postoperative pain levels between the two techniques using the FLACC score, which assesses facial expression, leg position, activity, crying, and consolability. Secondary objectives include the evaluation of intraoperative heart rate, blood pressure, and oxygen saturation, block application times, parental satisfaction, and the incidence of postoperative side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal Block Group | Active comparator | Procedure: caudal blockParticipants will receive an ultrasound-guided caudal epidural block with bupivacaine. |
| Erector spinae plane block group | Active comparator | Procedure: Erector Spinae Plane BlockParticipants will receive an ultrasound-guided erector spinae plane block with bupivacaine. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1 to 8 years
- Scheduled for elective lower abdominal surgery
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from parent(s) or legal guardian(s)
Key exclusion criteria (8 listed)
- Presence of anatomical abnormalities
- Coagulation disorders
- Infection at the site of block application
- Severe cardiovascular, neurological, respiratory, or metabolic disease
- Known allergy to study medications
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 blockA single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique. | Procedure or surgery | Caudal Block Group |
| Erector Spinae Plane BlockA single-shot ultrasound-guided erector spinae plane block will be performed at the L1 transverse process level using an in-plane technique. | Procedure or surgery | Erector spinae plane block group |
Primary outcome
FLACC pain score
Time frame: 0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery
Postoperative pain will be assessed using the FLACC scale. Unit of Measure: Score (0-10)
9 secondary outcomes
Time to first rescue analgesia
Time frame: Up to 24 hours postoperatively
Duration of Effective Analgesia
Time frame: Up to 24 hours postoperatively
Duration of Anesthesia
Time frame: Intraoperative period
Duration of Surgery
Time frame: Intraoperative period
Block Performance Time
Time frame: Intraoperative period
Intraoperative Heart Rate
Time frame: 0, 15, 30, 45 minutes and 1 hour after inductio
Intraoperative Mean Arterial Pressure
Time frame: 0, 15, 30, 45 minutes and 1 hour after induction
Intraoperative Oxygen Saturation
Time frame: 0, 15, 30, 45 minutes and 1 hour after induction
Postoperative Adverse Events
Time frame: First 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Zeki D Kuvet principal investigator
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
A study testing caudal block and Erector Spinae Plane Block in people with Caudal Epidural Anesthesia and Erector Spinae Plane Block, run by Ankara City Hospital Bilkent.
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 8 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vildan Ergen, Associate Professor (905321511040, vildanergen06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC pain score (time frame: 0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery). 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 11 May 2026.