LaparoscopicNCT06098105
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
A study testing Ultrasound-guided transversus abdominis plane block, Laparoscopic-assisted transversus abdominis plane block and Laparoscopic-assisted intraperitoneal instillation in people with Laparoscopic and Ultrasound, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 2 months to 7 years
- Conditions the study is for
- Laparoscopic, Ultrasound, Transversus Abdominis Plane Block
- What is being tested?
- Ultrasound-guided transversus abdominis plane block, Laparoscopic-assisted transversus abdominis plane block and Laparoscopic-assisted intraperitoneal instillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2023to 21 Apr 2024
- 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 2 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2 months to 7 years old
- Both sexes.
- American Society of Anesthesiologists (ASA) I-II.
- Schedule for elective unilateral inguinal hernia repair.
Who cannot join
- Patients with history of allergy.
- Hepatic and renal failure.
- Previous inguinal surgery.
- Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial
The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.
Read the detailed description
Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.
Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.
- Conditions
- Laparoscopic, Ultrasound, Transversus Abdominis Plane Block, Laparoscopic Intraperitoneal Instillation, Pediatrics, Inguinal Hernia Repair
- Being tested
- Ultrasound-guided transversus abdominis plane block, Laparoscopic-assisted transversus abdominis plane block, Laparoscopic-assisted intraperitoneal instillation, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided transversus abdominis plane blockProcedure or surgery
This group will receive ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.
Laparoscopic-assisted transversus abdominis plane blockProcedure or surgery
Patients will receive laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.
Laparoscopic-assisted intraperitoneal instillationProcedure or surgery
This group will receive laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.
BupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided transversus abdominis plane block | Active comparator | This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group. Receives: Procedure: Ultrasound-guided transversus abdominis plane block; Drug: Bupivacaine |
| Laparoscopic-assisted transversus abdominis plane block | Experimental | Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL. Receives: Procedure: Laparoscopic-assisted transversus abdominis plane block; Drug: Bupivacaine |
| Laparoscopic-assisted intraperitoneal instillation | Experimental | This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation. Receives: Procedure: Laparoscopic-assisted intraperitoneal instillation; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative pethidine consumption
The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is > 3, pethidine 0.5 mg/kg.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Post-operative pain scores
Face, Legs, Activity, Cry and Consolability (FLACC) scale will be used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain.
FLACC scale will be measured at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours.
Measured: 24 hours postoperatively
Time of first analgesia request.
Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.
Measured: 24 hours postoperatively
Incidence of adverse events
Complication related to the block or adverse events of the administered drugs.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start24 Oct 2023
- Primary completion21 Apr 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopicStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed Mohamed Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098105
- Sponsor's protocol ID
- 36264PR352/9/23
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06098105
- Acronym / sponsor ID
- 36264PR352/9/23
- Conditions
- Laparoscopic, Ultrasound, Transversus Abdominis Plane Block, Laparoscopic Intraperitoneal Instillation, Pediatrics, Inguinal Hernia Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 24 Oct 2023 (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 aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.
Detailed description
Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.
Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided transversus abdominis plane block | Active comparator | Procedure: Ultrasound-guided transversus abdominis plane block, Drug: BupivacaineThis group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group. |
| Laparoscopic-assisted transversus abdominis plane block | Experimental | Procedure: Laparoscopic-assisted transversus abdominis plane block, Drug: BupivacainePatients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL. |
| Laparoscopic-assisted intraperitoneal instillation | Experimental | Procedure: Laparoscopic-assisted intraperitoneal instillation, Drug: BupivacaineThis group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation. |
Who may qualify
- Ages
- 2 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 2 months to 7 years old
- Both sexes.
- American Society of Anesthesiologists (ASA) I-II.
- Schedule for elective unilateral inguinal hernia repair.
Key exclusion criteria (4 listed)
- Patients with history of allergy.
- Hepatic and renal failure.
- Previous inguinal surgery.
- Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
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 blockThis group will receive ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group. | Procedure or surgery | Ultrasound-guided transversus abdominis plane block |
| Laparoscopic-assisted transversus abdominis plane blockPatients will receive laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL. | Procedure or surgery | Laparoscopic-assisted transversus abdominis plane block |
| Laparoscopic-assisted intraperitoneal instillationThis group will receive laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation. | Procedure or surgery | Laparoscopic-assisted intraperitoneal instillation |
| Bupivacainebupivacaine | Drug | Laparoscopic-assisted intraperitoneal instillation, Laparoscopic-assisted transversus abdominis plane block, Ultrasound-guided transversus abdominis plane block |
Primary outcome
Total postoperative pethidine consumption
Time frame: 24 hours postoperatively
The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is > 3, pethidine 0.5 mg/kg.
3 secondary outcomes
Post-operative pain scores
Time frame: 24 hours postoperatively
Time of first analgesia request.
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 25 Apr 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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, Laparoscopic-assisted transversus abdominis plane block and Laparoscopic-assisted intraperitoneal instillation in people with Laparoscopic and Ultrasound, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 4 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 25 Apr 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 Egypt. 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?
Total postoperative pethidine consumption (time frame: 24 hours postoperatively). 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 25 Apr 2024.