AnalgesiaNCT06701162
TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY
A study testing Ultrasoud-guided TAP block and Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block in people with Analgesia and Ultrasound Guided Block, run by Tunis University at 1 site in Tunisia.
Trial summary
The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Analgesia, Ultrasound Guided Block
- What is being tested?
- Ultrasoud-guided TAP block and Ultrasound-guided Ilio-inguinal Ilio-Hypogatric 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 siteTunisia
- Study dates
- 1 Mar 2019to 27 Feb 2020
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 12 years
- ASA physical status 1 or 2
- Scheduled for unilateral inguinal surgery
Who cannot join
- Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
- Parental refusal
Trial locations and contacts
1 site in 1 country.
About this study
The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.
Read the detailed description
The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery. This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery. Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia. Analgesics were not systematically administered post-induction. Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed. At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary. Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home. Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.
- Conditions
- Analgesia, Ultrasound Guided Block
- Being tested
- Ultrasoud-guided TAP block, Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block
- Keywords
- Transverse abdominal plane bloc, pain, analgesia, ultrasound, children
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasoud-guided TAP blockProcedure or surgery
the ultrasound probe was placed at the mid-axillary line, and the needle was inserted into the space between the internal oblique and transverse muscles, splitting the inter-muscular fascia after injection of local anesthetic.
Ultrasound-guided Ilio-inguinal Ilio-Hypogatric blockProcedure or surgery
the ultrasound probe was positioned transversely on the abdominal wall at the contact point of the anterosuperior iliac spine. The needle was inserted into the space between the internal oblique and transverse muscles, causing separation of the intermuscular fascia layers upon injection of the anesthetic mixture
| Study group | Role | What they receive |
|---|---|---|
| TAP group | Other | Uktrasound-guided TAP block Receives: Procedure: Ultrasoud-guided TAP block |
| IIIH block | Other | Ultrasound-guided Ilio-inguinal Ilio-Hypogastric Block Receives: Procedure: Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of postoperative analgesia : PPMP score
The quality of postoperative analgesia described by the pain score : Postoperative Pain Measure for Parents (PPMP) score, minimum value is 0 , maximum value 10 , a value higher than 6 indicates a major pain .
Measured: 24 h after surgery
Secondary outcomes (2)
Block execution time
Measured: From the beginning of the practice of the block to the end
Complications related to the techniques of nerve block
Complications related to local anesthetics or block technique such as hematoma, spread of local anesthetic to the femoral nerve, intraperitoneal injection ...
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Mar 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were randomly assigned into two groups to receive after a standardized induction of general anesthesia either an ultrasound-guided TAP block or IIIH block with bupivacaine 0.3 ml/kg.
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06701162
- Sponsor's protocol ID
- 012020
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY
- ClinicalTrials.gov ID
- NCT06701162
- Acronym / sponsor ID
- 012020
- Conditions
- Analgesia, Ultrasound Guided Block
- Keywords
- Transverse abdominal plane bloc, pain, analgesia, ultrasound, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 22 Nov 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.
The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.
Detailed description
The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery. This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery. Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia. Analgesics were not systematically administered post-induction. Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed. At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary. Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home. Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients were randomly assigned into two groups to receive after a standardized induction of general anesthesia either an ultrasound-guided TAP block or IIIH block with bupivacaine 0.3 ml/kg.
| Arm | Type | Receives |
|---|---|---|
| TAP group | Other | Procedure: Ultrasoud-guided TAP blockUktrasound-guided TAP block |
| IIIH block | Other | Procedure: Ultrasound-guided Ilio-inguinal Ilio-Hypogatric blockUltrasound-guided Ilio-inguinal Ilio-Hypogastric Block |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 months to 12 years
- ASA physical status 1 or 2
- Scheduled for unilateral inguinal surgery
Key exclusion criteria (2 listed)
- Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
- Parental refusal
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 |
|---|---|---|
| Ultrasoud-guided TAP blockthe ultrasound probe was placed at the mid-axillary line, and the needle was inserted into the space between the internal oblique and transverse muscles, splitting the inter-muscular fascia after injection of local anesthetic. | Procedure or surgery | TAP group |
| Ultrasound-guided Ilio-inguinal Ilio-Hypogatric blockthe ultrasound probe was positioned transversely on the abdominal wall at the contact point of the anterosuperior iliac spine. The needle was inserted into the space between the internal oblique and transverse muscles, causing separation of the intermuscular fascia layers upon injection of the anesthetic mixture | Procedure or surgery | IIIH block |
Primary outcome
Quality of postoperative analgesia : PPMP score
Time frame: 24 h after surgery
The quality of postoperative analgesia described by the pain score : Postoperative Pain Measure for Parents (PPMP) score, minimum value is 0 , maximum value 10 , a value higher than 6 indicates a major pain .
2 secondary outcomes
Block execution time
Time frame: From the beginning of the practice of the block to the end
Complications related to the techniques of nerve block
Time frame: Perioperative
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 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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 Ultrasoud-guided TAP block and Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block in people with Analgesia and Ultrasound Guided Block, 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 3 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 22 Nov 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 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?
Quality of postoperative analgesia : PPMP score (time frame: 24 h after surgery). 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 22 Nov 2024.