- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426939
Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vildan Ergen, Associate Professor
- Phone Number: 905321511040
- Email: vildanergen06@gmail.com
Study Contact Backup
- Name: Zeki D Kuvet, MD
- Phone Number: 905397959579
- Email: zekidemirhankuvet@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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)
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Caudal Block Group
Participants will receive an ultrasound-guided caudal epidural block with bupivacaine.
|
A single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique.
|
|
Active Comparator: Erector spinae plane block group
Participants will receive an ultrasound-guided erector spinae plane block with bupivacaine.
|
A single-shot ultrasound-guided erector spinae plane block will be performed at the L1 transverse process level using an in-plane technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue analgesia
Time Frame: Up to 24 hours postoperatively
|
Time from the end of surgery to the first administration of rescue analgesic
|
Up to 24 hours postoperatively
|
|
Duration of Effective Analgesia
Time Frame: Up to 24 hours postoperatively
|
Time from block application to the first FLACC pain score ≥4
|
Up to 24 hours postoperatively
|
|
Duration of Anesthesia
Time Frame: Intraoperative period
|
Time from anesthesia induction to awake extubation
|
Intraoperative period
|
|
Duration of Surgery
Time Frame: Intraoperative period
|
Time from skin incision to skin closure
|
Intraoperative period
|
|
Block Performance Time
Time Frame: Intraoperative period
|
Time from needle insertion to completion of block procedure
|
Intraoperative period
|
|
Intraoperative Heart Rate
Time Frame: 0, 15, 30, 45 minutes and 1 hour after inductio
|
Heart rate measured intraoperatively
|
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
|
Mean arterial pressure measured intraoperatively
|
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
|
Peripheral oxygen saturation measured intraoperatively
|
0, 15, 30, 45 minutes and 1 hour after induction
|
|
Postoperative Adverse Events
Time Frame: First 24 hours postoperatively
|
Incidence of postoperative adverse events including nausea, vomiting, nerve injury, or infection
|
First 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeki D Kuvet, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED 1-25-1436
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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