Caudal block
ProcedureA single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique.
NCT Number: NCT07426939
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.
Trial opening soon.
Get Notified1 year–8 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
A single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique.
A single-shot ultrasound-guided erector spinae plane block will be performed at the L1 transverse process level using an in-plane technique.
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)
Time frame: Up to 24 hours postoperatively
Time from the end of surgery to the first administration of rescue analgesic
Time frame: Up to 24 hours postoperatively
Time from block application to the first FLACC pain score ≥4
Time frame: Intraoperative period
Time from anesthesia induction to awake extubation
Time frame: Intraoperative period
Time from skin incision to skin closure
Time frame: Intraoperative period
Time from needle insertion to completion of block procedure
Time frame: 0, 15, 30, 45 minutes and 1 hour after inductio
Heart rate measured intraoperatively
Time frame: 0, 15, 30, 45 minutes and 1 hour after induction
Mean arterial pressure measured intraoperatively
Time frame: 0, 15, 30, 45 minutes and 1 hour after induction
Peripheral oxygen saturation measured intraoperatively
Time frame: First 24 hours postoperatively
Incidence of postoperative adverse events including nausea, vomiting, nerve injury, or infection
Contact information is provided by the study sponsor or research team.
Vildan Ergen, Associate Professor
CONTACT
Zeki D Kuvet, MD
CONTACT
Ankara City Hospital Bilkent
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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