Transversus Abdominis Plane BlockNCT04927624
Transversus Abdominis Plane Block Versus Quoadratus Lumborum Block on Infants
A study testing transversus abdominis plane block and quoadratus lumborum block in people with Transversus Abdominis Plane Block and Quoadratus Lumborum Block, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Transversus Abdominis Plane Block, Quoadratus Lumborum Block
- What is being tested?
- transversus abdominis plane block and quoadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Oct 2021
- 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 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 month to 1 year
- who were scheduled for unilateral inguinal hernia operation
- American Society of Anesthesiologists (ASA) physical score I-II
Who cannot join
- Patients with ASA II-IV
- coagulopathy
- skin infection at the block application site
- bupivacaine allergy
- bilateral inguinal hernia operation
- additional operation in different region
Show all 9Show fewer
- laparoscopic inguinal hernia operation
- younger than 1 month
- with a history of prematurity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Etfal Research and Training Hospital
Istanbul, 34371
mustafa altınay, 05333914422, m_altinay@yahoo.com
About this study
Official title: Comparison of Postoperative Analgesic Efficiency of Transversus Abdominis Plane Block and Quoadratus Lumborum Block on Infants Who Underwent Single Sided Inguinal Hernia Repair: A Randomised Controlled Trial
we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.
Read the detailed description
Infants are more sensitive to the side effects of general anesthesia than older children. This may be associated with the incomplete maturation of organ systems effective in pharmacodynamics. Regional anesthesia applications provide safe and effective analgesia by reducing the need for opioids. Regional anesthesia applications in infants require experience and complication rates due to central blocks are high. However, in recent years, the use of ultrasound (USG) has increased the use of safe and effective trunk blocks. There are studies on the use of Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block (QLB) in children. However, there is no comparative study on its use in infants.
In our study, we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.
- Being tested
- transversus abdominis plane block, quoadratus lumborum block
- Keywords
- infant, analgesic efficiency, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockProcedure or surgery
Also called quoadratus lumborum block
The transversus abdominis plane (TAP) block was first introduced by Rafi et al. in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle. Since the thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall , the local anesthetic spread in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall.
quoadratus lumborum blockProcedure or surgery
quoadratus lumborum block
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane | Active comparator | In the group in which Transversus Abdominis Plan Block was applied, the patient was placed in the supine position. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and the anterolateral abdominal wall. After visualizing the external-internal obliq and transversus abdominis muscles, 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration by advancing the needle into the fascia between the internal obliq muscle and the transversus abdominis muscle with the in-plane technique. Receives: Procedure: transversus abdominis plane block |
| quoadratus lumborum block | Active comparator | In the Quadratus Lumborum Block (Lateral approach) group, the patient was placed in the lateral position with the side to be blocked on top. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and costa edge. After visualizing the extarnal-internal obliq and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum muscle and thoracolumbar fascia were visualized. The needle was advanced to the anterolateral border of the quadratus lumborum muscle with the in-plane technique and 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration. Receives: Procedure: quoadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC
Face, Legs, Activitiy, Cry, Consolability score
Measured: up to 24 hours
first analgesic need times
time of first analgesic need after surgery
Measured: up to 24 hours
Secondary outcomes (2)
frequency of need for analgesics
Frequency of analgesic requirement in the first 24 hours after the operation
Measured: up to 24 hours
complications
post-operative anesthetic complications
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jun 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis Plane 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Ay Sayin, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927624
- Sponsor's protocol ID
- 33334
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficiency of Transversus Abdominis Plane Block and Quoadratus Lumborum Block on Infants Who Underwent Single Sided Inguinal Hernia Repair: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04927624
- Acronym / sponsor ID
- 33334
- Keywords
- infant, analgesic efficiency, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 16 Jun 2021 (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.
we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.
Detailed description
Infants are more sensitive to the side effects of general anesthesia than older children. This may be associated with the incomplete maturation of organ systems effective in pharmacodynamics. Regional anesthesia applications provide safe and effective analgesia by reducing the need for opioids. Regional anesthesia applications in infants require experience and complication rates due to central blocks are high. However, in recent years, the use of ultrasound (USG) has increased the use of safe and effective trunk blocks. There are studies on the use of Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block (QLB) in children. However, there is no comparative study on its use in infants.
In our study, we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane | Active comparator | Procedure: transversus abdominis plane blockIn the group in which Transversus Abdominis Plan Block was applied, the patient was placed in the supine position. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and the anterolateral abdominal wall. After visualizing the external-internal obliq and transversus abdominis muscles, 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration by advancing the needle into the fascia between the internal obliq muscle and the transversus abdominis muscle with the in-plane technique. |
| quoadratus lumborum block | Active comparator | Procedure: quoadratus lumborum blockIn the Quadratus Lumborum Block (Lateral approach) group, the patient was placed in the lateral position with the side to be blocked on top. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and costa edge. After visualizing the extarnal-internal obliq and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum muscle and thoracolumbar fascia were visualized. The needle was advanced to the anterolateral border of the quadratus lumborum muscle with the in-plane technique and 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1 month to 1 year
- who were scheduled for unilateral inguinal hernia operation
- American Society of Anesthesiologists (ASA) physical score I-II
Key exclusion criteria (9 listed)
- Patients with ASA II-IV
- coagulopathy
- skin infection at the block application site
- bupivacaine allergy
- bilateral inguinal hernia operation
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 |
|---|---|---|
| transversus abdominis plane blockAlso: quoadratus lumborum blockThe transversus abdominis plane (TAP) block was first introduced by Rafi et al. in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle. Since the thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall , the local anesthetic spread in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall. | Procedure or surgery | transversus abdominis plane |
| quoadratus lumborum blockquoadratus lumborum block | Procedure or surgery | quoadratus lumborum block |
Primary outcome
FLACC
Time frame: up to 24 hours
Face, Legs, Activitiy, Cry, Consolability score
first analgesic need times
Time frame: up to 24 hours
time of first analgesic need after surgery
2 secondary outcomes
frequency of need for analgesics
Time frame: up to 24 hours
complications
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversus abdominis plane block and quoadratus lumborum block in people with Transversus Abdominis Plane Block and Quoadratus Lumborum Block, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Jun 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 16 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.