Postoperative AnalgesiaNCT06530147
Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries
An observational study of Postoperative Analgesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Transversalis Fascia Plane Block and Transversus Abdominis Plane Block
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 6 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged between 1 and 7 years who will undergo abdominal surgery will be included in the study.
Who may be able to join
- American Society of Anesthesiologist Classification (ASA) I-II patients
- 1-7 aged patients
- patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)
Who cannot join
- Use of anticoagulants
- Allergy of medications to be used
- Presence of infection the area where the block will be applied
- American Society of Anesthesiologist Classification (ASA) III-IV patients
- The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
- Patients who do not agree to participate in the research, parents/legal guardians
- Patients who were operated on with a different incision than planned for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries
In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries
Read the detailed description
After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.
- Conditions
- Postoperative Analgesia
- Being tested
- Transversalis Fascia Plane Block, Transversus Abdominis Plane Block
- Keywords
- Regional anaesthesia, Transversus Abdominis Plane Block, Transversalis Fascia Plane Block, Pediatric Lower Abdominal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane BlockOther
One-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.
Transversus Abdominis Plane BlockOther
One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascia Plane Block | One-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. Receives: Other: Transversalis Fascia Plane Block | |
| Transversus Abdominis Plane Block | One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. Receives: Other: Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.
Measured: at the 6th postoperative hou
Secondary outcomes (5)
Pain scores
Secondary objectives will include comparison of patient FLACC (Face, Legs, Activity, Cry, Consolability) pain scores in 24-hour observations of patients. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.
Measured: During postoperative 24 hours
Need for analgesic
It should be recorded whether there is a need for analgesics.
Measured: During postoperative 24 hours
Nause and vomiting
The presence or absence of nausea and vomiting symptoms will be recorded.
Measured: During postoperative 24 hours
Parents satisfaction
Parental satisfaction was assessed on a scale ranging from 1 to 5 points parents satisfaction with the applied analgesia methods was evaluated on a scale from 1, indicating the lowest satisfaction, to 5, indicating the highest satisfaction.
Measured: During postoperative 24 hours
Time elapsed until the first analgesic requirement
What type of analgesic is needed. The time elapsed until the first analgesic requirement was recorded.
Measured: During postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start15 Jun 2022
- Primary completion29 Jul 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasibe Irban, Kocaeli University
- Investigators
- Can Aksu, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530147
- Sponsor's protocol ID
- KAEK/06.bl.02
- Status last verified
- Aug 2024
- First submitted
- 5 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Irban H, Aksu C. Comparison of the effectiveness of transversalis fascia plane block and transversus abdominis plane block for postoperative analgesia in pediatric lower abdominal surgeries: prospective, single blinded study. BMC Anesthesiol. 2025 Apr 5;25(1):154. doi: 10.1186/s12871-025-03023-z.
PubMed 40188032
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06530147
- Acronym / sponsor ID
- KAEK/06.bl.02
- Conditions
- Postoperative Analgesia
- Keywords
- Regional anaesthesia, Transversus Abdominis Plane Block, Transversalis Fascia Plane Block, Pediatric Lower Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 31 Jul 2024 (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.
In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries
Detailed description
After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascia Plane Block | – | Other: Transversalis Fascia Plane BlockOne-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. |
| Transversus Abdominis Plane Block | – | Other: Transversus Abdominis Plane BlockOne-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged between 1 and 7 years who will undergo abdominal surgery will be included in the study.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist Classification (ASA) I-II patients
- 1-7 aged patients
- patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)
Key exclusion criteria (7 listed)
- Use of anticoagulants
- Allergy of medications to be used
- Presence of infection the area where the block will be applied
- American Society of Anesthesiologist Classification (ASA) III-IV patients
- The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
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 |
|---|---|---|
| Transversalis Fascia Plane BlockOne-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. | Other | Transversalis Fascia Plane Block |
| Transversus Abdominis Plane BlockOne-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery. | Other | Transversus Abdominis Plane Block |
Primary outcome
Pain scores
Time frame: at the 6th postoperative hou
Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.
5 secondary outcomes
Pain scores
Time frame: During postoperative 24 hours
Need for analgesic
Time frame: During postoperative 24 hours
Nause and vomiting
Time frame: During postoperative 24 hours
Parents satisfaction
Time frame: During postoperative 24 hours
Time elapsed until the first analgesic requirement
Time frame: During postoperative 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 9 Aug 2024.
- Derived from this study: PubMed 40188032Irban H, Aksu C. Comparison of the effectiveness of transversalis fascia plane block and transversus abdominis plane block for postoperative analgesia in pediatric lower abdominal surgeries: prospective, single blinded study. BMC Anesthesiol. 2025 Apr 5;25(1):154. doi: 10.1186/s12871-025-03023-z.
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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.
Can Aksu study director
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Analgesia, run by Kocaeli University 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 7 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 9 Aug 2024. 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?
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?
Pain scores (time frame: at the 6th postoperative hou). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530147, which also lists 1 linked publication.
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 9 Aug 2024.