- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06861556
Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children
Pediatric Transversus Abdominis Plane Block Versus Quadratus Lumborum Block: a Prospective Randomized Study in Sub-umbilical Peripheral Surgery
Although abdominal wall surgeries are also as routinely performed on pediatric patients, postoperative pain in children has remained under-researched compared to adults. Consequently, there has been a growing need for adapting regional analgesia to this distinct population. While the Transversus Abdominis Plane Block (TAPB) and Quadratus Lumborum Block (QLB) have been established as potent sensory blocks in adult practice, data on their efficiency in pediatric abdominal parietal surgeries remain scarce.
The investigators aimed to compare the analgesic effect of lateral TAPB versus posterior QLB in children undergoing elective abdominal wall surgery.
Study Overview
Status
Detailed Description
Randomized controlled trial, including pediatric patients aged from 1 to 10 years old scheduled for an elective outpatient open sub-umbilical abdominal wall surgery.
After a standardized anesthesia induction protocol, patients were randomized into two parallel groups receiving either a lateral TAPB or a posterior QLB.
The investigators determined the time to first rescue analgesia as the primary outcome of the present trial. As for secondary outcomes, the investigators set out to comparatively assess block failure rates, intra operative hemodynamic features pain scores consisting of FLACC scale values, analgesic consumption attested by the number of administrated rescue paracetamol doses along the cumulative administered dose per kilogram of weight within the first postoperative 24 hours, as well as the incidence of side effects namely systemic local anesthetic toxicity symptoms, PONV, urinary retention, ICU admission or re-intervention for block-related complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tunis, Tunisia, 1029
- Bechir Hamza Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- We included patients aged from 1 to 10 years old with American Society of Anesthesiologists (ASA) physical status I or II.
Exclusion Criteria:
- Non-inclusion criteria were a priorly known allergy to local anesthetics, a priorly known or suspected coagulopathy, inflammation or infection at the needle injection site, cognitive impairment preventing standard pain assessment and associated circumcision or scrotal incision.
- Later on after allocation, patients were excluded for block failure or major perioperative complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP block group
Ultrasound-guided TAP block group
|
The operator applied a linear ultrasound probe transversally to the mid-axillary line between the costal margin and iliac crest.
Landmarks were then identified as three muscles layers beneath the subcutaneous tissue; from external to internal lay respectively the external oblique muscle (EO), the internal oblique muscle (IO) and the transversus abdominis (TA).
The needle was inserted in plane from the iliac crest level on the midaxillary line advancing towards the midline to the fascia laying between the IO and the TA muscles until pop detection.
A clear aspiration ruled out vascular effraction.
Finally, the space between the two muscle planes was hydrodissected with the bupivacaine.The end goal was visualizing the IO moving upward leaving room to a hypoechoic lens-shaped local anesthetic distribution.
|
|
Active Comparator: QLB block group
Ultrasound-guided Quadratus Lumborum block group
|
The patient was laid in a lateral decubitus position.
The operator applied the probe transversally on the iliac crest directing the indicator to display the back muscles encompassed by the thoracolumbar fascia (TLF).The intended image was spotted by the emergence of the transverse process L4, delimiting the stem of a shamrock-like shape.
Quadratus lumborum (QL) muscle represented the upper leaf of the shamrock, and psoas major (PM) and erector spinae (ES) stood respectively for the anterior and posterior leaves.
The needle was inserted in plane from the postero-median lumbar wall directed antero-laterally with tip aiming at the posterior border of the QL muscle adjacent to the ES muscles.
Pop detection indicated the middle TLF where the local anesthetic would spread, homogenous and resistance-free
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue analgesia
Time Frame: 3 hours
|
Time (in minutes) from the completion of the block to first analgesia administration based on postoperative pain score (assessed using FLACC (Face Legs Activity Crying Consolability) in ward >3)
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
block Failure rate
Time Frame: 30 minutes
|
percentage of failed blocks in both groups
|
30 minutes
|
|
FLACC scale pain scores
Time Frame: 2 hours
|
Post operative analgesia was assessed using the following measures: - pain scores including the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, recorded at H0, H1, H2 |
2 hours
|
|
PPMP scale scores
Time Frame: 24 hours
|
Parents' Postoperative Pain Measure scores after discharge (at H6, H12, and H24 post operative).
|
24 hours
|
|
Total analgesic consumption
Time Frame: 24 hours
|
determined by the total number of rescue paracetamol doses administered (mg per kilogram of weight)
|
24 hours
|
|
Post operative nausea and vomiting (PONV)
Time Frame: 24 hours
|
incidence (percentage) of post operative nausea and vomiting in both groups
|
24 hours
|
|
Urinary retention
Time Frame: 24 hours
|
incidence (percentage) of post operative Urinary retention in both groups
|
24 hours
|
Collaborators and Investigators
Sponsor
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
- 222022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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