- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07301528
Comparison of ESP and QL Blocks for Postoperative Pain in Pediatric Appendectomy (ESP-QLB) (ESP-QLB)
Comparative Effects of Erector Spinae Plane and Quadratus Lumborum Blocks on Postoperative Pain and Analgesic Requirement in Pediatric Appendectomy: A Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Appendectomy is one of the most common emergency surgical procedures in children, and effective postoperative analgesia plays a key role in patient comfort, early mobilization, and reduced opioid exposure. Regional anesthesia techniques have gained increasing importance in pediatric anesthesia due to their opioid-sparing effect and favorable safety profile. Among these techniques, the Erector Spinae Plane (ESP) block and the Quadratus Lumborum (QL) block have shown promising results; however, there is a lack of high-quality randomized controlled trials directly comparing their clinical efficacy in pediatric appendectomy.
This study will prospectively enroll pediatric patients between 3 and 13 years of age who are scheduled to undergo appendectomy. After obtaining informed parental consent, participants will be randomly allocated to either the ESP block group or the QL block group. All blocks will be performed under ultrasound guidance using 0.25% bupivacaine at a dose of 0.5 mL/kg following the induction of general anesthesia. Standardized postoperative analgesia protocols will be applied to all participants.
Pain scores will be measured at predefined time points using a validated pediatric pain scale. Secondary outcomes will include total opioid consumption during the first 24 hours, the time to first rescue analgesic requirement, mobilization time, length of hospital stay, parental satisfaction scores, and any block-related complications. Patient data will be collected by trained investigators who will be blinded to group allocation.
The goal of this trial is to determine whether ESP or QL block provides superior postoperative pain control and recovery in pediatric appendectomy. The results may contribute to evidence-based recommendations for regional anesthesia selection in pediatric surgical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kütahya, Turkey (Türkiye), 43100
- Kutahya City Hospital
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Kütahya
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Kütahya, Kütahya, Turkey (Türkiye), 43100
- Kutahya City Hospital Anesthesia and Reanimation Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 3-13 years
- Diagnosis of acute appendicitis requiring appendectomy
- ASA physical status I-II
- Planned general anesthesia with intraoperative regional block (ESP or QL block)
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Refusal of regional block by family or anesthesia team
- Coagulopathy or anticoagulant medication use
- Local infection at the block injection site
- Known allergy or contraindication to local anesthetics
- Neurological or neuromuscular disorders
- Cognitive impairment preventing postoperative pain assessment
- Conversion to open surgery
- Intraoperative complications requiring deviation from study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: QLB Block
Ultrasound-guided transmuscular QL block using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.
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Ultrasound-guided transmuscular QL block performed under general anesthesia using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.
|
|
Active Comparator: ESP Block
Ultrasound-guided ESP block at the L1 level using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.
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Ultrasound-guided ESP block at the L1 level under general anesthesia using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score
Time Frame: Pain scores will be assessed at 1, 6, 12, and 24 postoperative hours.
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Pain intensity will be evaluated at rest using the Oucher Pain Rating Scale.
Higher scores indicate greater pain.
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Pain scores will be assessed at 1, 6, 12, and 24 postoperative hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Analgesic Consumption
Time Frame: Recorded during the first 24 hours after surgery
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Total dose of analgesic medications (NSAIDs and/or non-opioid analgesics) administered within the first 24 hours after surgery will be recorded.
Higher values indicate greater analgesic requirement.
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Recorded during the first 24 hours after surgery
|
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Time to First Analgesic Requirement
Time Frame: From the end of surgery until the first documented analgesic requirement, assessed up to 24 hours postoperatively
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Time interval between the end of surgery and the first administration of rescue analgesia will be recorded in minutes.
Longer intervals indicate better analgesic effectiveness.
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From the end of surgery until the first documented analgesic requirement, assessed up to 24 hours postoperatively
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Time to Mobilization
Time Frame: From the end of surgery until the first successful ambulation with or without assistance, assessed up to 24 hours postoperatively
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Time from the end of surgery until the patient is able to ambulate with assistance or independently will be recorded in minutes.
Shorter time indicates faster functional recovery.
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From the end of surgery until the first successful ambulation with or without assistance, assessed up to 24 hours postoperatively
|
|
Length of Hospital Stay
Time Frame: From the end of surgery until hospital discharge, typically within 24-48 hours.
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Duration of hospitalization will be recorded from admission to discharge and expressed in hours.
Longer duration indicates delayed recovery.
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From the end of surgery until hospital discharge, typically within 24-48 hours.
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Parents' Postoperative Pain Measure (PPPM)
Time Frame: Assessed at 1, 6, 12, and 24 hours postoperatively
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Postoperative pain will be evaluated by parents using the Parents' Postoperative Pain Measure (PPPM).
Higher scores indicate greater pain intensity.
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Assessed at 1, 6, 12, and 24 hours postoperatively
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Block-Related Complications
Time Frame: From block performance until the end of surgery and during the first 24 hours postoperatively
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ny adverse events potentially related to the regional block (e.g., local hematoma or bruising, infection at the injection site, neurological symptoms, or suspected local anesthetic systemic toxicity) will be recorded as present or absent.
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From block performance until the end of surgery and during the first 24 hours postoperatively
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Block performance time
Time Frame: During block performance, prior to surgical incision
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Block performance time was defined as the time (in seconds) from the initial placement of the ultrasound probe on the skin to the completion of local anesthetic injection.
The duration was recorded by an independent observer using a stopwatch.
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During block performance, prior to surgical incision
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Süleyman Camgöz, Kütahya Health Sciences University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBU-ESPQL-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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