Peripheral Nerve BlockNCT06861556
Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children
A study testing Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25% and Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25% in people with Peripheral Nerve Block and Post Operative Analgesia, run by Tunis University at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Peripheral Nerve Block, Post Operative Analgesia, Ultrasound-guided Regional Anesthesia
- What is being tested?
- Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25% and Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- We included patients aged from 1 to 10 years old with American Society of Anesthesiologists (ASA) physical status I or II.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%, Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%
- Keywords
- Transversus Abdominis Plane block, QUADRATUS LUMBORUM BLOCK, post operative analgesia, Ultrasound, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%Procedure or surgery
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.
Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| TAP block group | Active comparator | Ultrasound-guided TAP block group Receives: Procedure: Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25% |
| QLB block group | Active comparator | Ultrasound-guided Quadratus Lumborum block group Receives: Procedure: Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
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)
Measured: 3 hours
Secondary outcomes (6)
block Failure rate
percentage of failed blocks in both groups
Measured: 30 minutes
FLACC scale pain scores
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
Measured: 2 hours
PPMP scale scores
Parents' Postoperative Pain Measure scores after discharge (at H6, H12, and H24 post operative).
Measured: 24 hours
Total analgesic consumption
determined by the total number of rescue paracetamol doses administered (mg per kilogram of weight)
Measured: 24 hours
Post operative nausea and vomiting (PONV)
incidence (percentage) of post operative nausea and vomiting in both groups
Measured: 24 hours
Urinary retention
incidence (percentage) of post operative Urinary retention in both groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Oct 2022
- Primary completion31 Mar 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve BlockStudies of the same condition, open and under way.
- 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
- Model description
- The patients were randomly assigned into two groups to receive after a standardized general anesthesia induction either an ultrasound-guided TAP block or Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861556
- Sponsor's protocol ID
- 222022
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Transversus Abdominis Plane Block Versus Quadratus Lumborum Block: a Prospective Randomized Study in Sub-umbilical Peripheral Surgery
- ClinicalTrials.gov ID
- NCT06861556
- Acronym / sponsor ID
- 222022
- Keywords
- Transversus Abdominis Plane block, QUADRATUS LUMBORUM BLOCK, post operative analgesia, Ultrasound, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 6 Mar 2025 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients were randomly assigned into two groups to receive after a standardized general anesthesia induction either an ultrasound-guided TAP block or Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%
| Arm | Type | Receives |
|---|---|---|
| TAP block group | Active comparator | Procedure: Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%Ultrasound-guided TAP block group |
| QLB block group | Active comparator | Procedure: Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%Ultrasound-guided Quadratus Lumborum block group |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- We included patients aged from 1 to 10 years old with American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%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. | Procedure or surgery | TAP block group |
| Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%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 | Procedure or surgery | QLB block group |
Primary outcome
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)
6 secondary outcomes
block Failure rate
Time frame: 30 minutes
FLACC scale pain scores
Time frame: 2 hours
PPMP scale scores
Time frame: 24 hours
Total analgesic consumption
Time frame: 24 hours
Post operative nausea and vomiting (PONV)
Time frame: 24 hours
Urinary retention
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25% and Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25% in people with Peripheral Nerve Block and Post Operative Analgesia, run by Tunis University at 1 site in Tunisia.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesia (time frame: 3 hours). 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 6 Mar 2025.