Post Operative PainM-TAPANCT07540689
The Analgesic Efficacy of M-TAPA for Laparoscopic Abdominal Surgery in Children
A study testing port site infiltration and M-TAPA in people with Post Operative Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery. Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- port site infiltration and M-TAPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age (1-7) years.
- Both genders.
- American Society of Anaesthesiologists (ASA) - physical status I-II.
- Children undergoing elective laparoscopic abdominal surgery.
Who cannot join
- Parental refusal.
- Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Analgesic Efficacy of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Laparoscopic Abdominal Surgery in Children: Randomized Controlled Trial
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.
Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.
Read the detailed description
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.
Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to a port site local anesthetic infiltration. or M-TAPA.
- port-site local anesthetic infiltration Before the skin incision, the surgeon will inject 0.17 mL/kg of 0.25% bupivacaine (up to 2 mg/kg) via infiltration into the skin, subcutaneous tissue, and muscle fascia at the three laparoscopic ports.
- M-TAPA. Before skin incision, Ultrasound will be used to perform bilateral M-TAPA.0.25 mL/kg of 0.25% bupivacaine will be administered at each side.
- Conditions
- Post Operative Pain
- Being tested
- port site infiltration, M-TAPA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
port site infiltrationProcedure or surgery
children will receive port site LA infiltration.
M-TAPAProcedure or surgery
Children will receive bilateral M-TAPA regional anesthesia block.
| Study group | Role | What they receive |
|---|---|---|
| port site infiltration | Active comparator | Children will receive port site LA infiltration. Receives: Procedure: port site infiltration |
| M-TAPA | Active comparator | Children will receive bilaterall ultrasound guided M-TAPA block. Receives: Procedure: M-TAPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC pain score
The FLACC (Face, Leg, Activity, Cry, Consolability) pain score ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable, 1-3: mild discomfort, 4-6: moderate discomfort, \& 7-10: severe discomfort ) (FLACC) scale pain score at 6 hours.
Measured: 6 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540689
- Sponsor's protocol ID
- MD-402-2025
- Acronym
- M-TAPA
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Laparoscopic Abdominal Surgery in Children: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07540689
- Acronym / sponsor ID
- M-TAPA / MD-402-2025
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.
Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.
Detailed description
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.
Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to a port site local anesthetic infiltration. or M-TAPA.
- port-site local anesthetic infiltration Before the skin incision, the surgeon will inject 0.17 mL/kg of 0.25% bupivacaine (up to 2 mg/kg) via infiltration into the skin, subcutaneous tissue, and muscle fascia at the three laparoscopic ports.
- M-TAPA. Before skin incision, Ultrasound will be used to perform bilateral M-TAPA.0.25 mL/kg of 0.25% bupivacaine will be administered at each side.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| port site infiltration | Active comparator | Procedure: port site infiltrationChildren will receive port site LA infiltration. |
| M-TAPA | Active comparator | Procedure: M-TAPAChildren will receive bilaterall ultrasound guided M-TAPA block. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age (1-7) years.
- Both genders.
- American Society of Anaesthesiologists (ASA) - physical status I-II.
- Children undergoing elective laparoscopic abdominal surgery.
Key exclusion criteria (4 listed)
- Parental refusal.
- Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
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 |
|---|---|---|
| port site infiltrationchildren will receive port site LA infiltration. | Procedure or surgery | port site infiltration |
| M-TAPAChildren will receive bilateral M-TAPA regional anesthesia block. | Procedure or surgery | M-TAPA |
Primary outcome
FLACC pain score
Time frame: 6 hours postoperatively.
The FLACC (Face, Leg, Activity, Cry, Consolability) pain score ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable, 1-3: mild discomfort, 4-6: moderate discomfort, \& 7-10: severe discomfort ) (FLACC) scale pain score at 6 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing port site infiltration and M-TAPA in people with Post Operative Pain, run by Kasr El Aini Hospital 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Elhaddad, Ass.prof. (01224042847 ext. 02, drblacksmith@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC pain score (time frame: 6 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 23 Apr 2026.