Appendicitis AcutePABLONCT04969133
TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
A study testing Levobupivacaine Hydrochloride 2.5 MG/ML in people with Appendicitis Acute and Pediatrics, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Appendicitis Acute, Pediatrics, Analgesia
- What is being tested?
- Levobupivacaine Hydrochloride 2.5 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2021to 31 Jan 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age betwween 3 and 15 years
- Weight < or = 50 kg
- indicaction of coelioscopic appendicectomy
- ASA 1,2 or 3
- consent of the children and the holder of parental autority
Who cannot join
- Age<3 years or > 15years or weight > 50kg
- refusal of the children and the holder of parental autority
- ASA 4
- Peritonitis
- Patients with long term morphinic traitment
- Epilepsy
Show all 9Show fewer
- Hepato-cellular insuffisiancy
- local anesthesia allergy or nalbuphine allergy
- coagulation abnomrmality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.
Read the detailed description
This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.
- Conditions
- Appendicitis Acute, Pediatrics, Analgesia
- Being tested
- Levobupivacaine Hydrochloride 2.5 MG/ML
- Keywords
- Appendicectomy, Laparoscopy, infiltration, TAP block
- Medical subject headings
- Appendicitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine Hydrochloride 2.5 MG/MLDrug
To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | Transverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side.
The patient receives usual analgesia protocol. Receives: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML |
| local infiltration of the trocar wounds | Active comparator | local infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening.
The patient receives usual analgesia protocol. Receives: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative dose of nalbuphine in the 24 first hours post surgery
recording in mg/kg
Measured: 24 hours
Secondary outcomes (9)
cumulative dose of nalbuphine H0-H12 post surgery
recording in mg/kg
Measured: from beginning to 12th hour
cumulative dose of nalbuphine H13-H24 post surgery
recording in mg/kg
Measured: From 13th hour to 24th hour
FLACC analgesia score at H1 H2 H6 H12 H24
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Measured: FLACC score will be performed from awakenig to 24 hours post surgery
FLACC score mean
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Measured: FLACC score will be performed from awakenig to 24 hours surgery
individual variations of FLACC score
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
Measured: FLACC score will be performed from awakenig to 24 hours surgery
timing of first injection of nalbuphine
recording date and time of first injection
Measured: in the first 24 post operative hours
incidence of post operative nausea and vomiting
recording the incidence post operative nausea and vomiting
Measured: in the first 24 post operative hours
timing of first standing up
recording date and time of first standing up
Measured: in the first 24 post operative hours
adverse events
adverse event monitoring
Measured: in the first 24 post operative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start30 Jul 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 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 Appendicitis AcuteStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969133
- Sponsor's protocol ID
- 2021/571
- Acronym
- PABLO
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bloy G, Jurine A, Pili-Floury S, Auber F, Hild O, Guinot PG, Bouhemad B, Francois M, Vettoretti L, Bronnert R, Nguyen M, Chaussy Y, Besch G. Clinical effectiveness of transversus abdominis plane block versus local anaesthesia wound infiltration for postoperative pain relief after laparoscopic appendicectomy in children: A multicentre, double-blind, randomised, controlled phase III trial. Eur J Anaesthesiol. 2026 Mar 4. doi: 10.1097/EJA.0000000000002367. Online ahead of print.
PubMed 41777031
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
- ClinicalTrials.gov ID
- NCT04969133
- Acronym / sponsor ID
- PABLO / 2021/571
- Conditions
- Appendicitis Acute, Pediatrics, Analgesia
- Keywords
- Appendicectomy, Laparoscopy, infiltration, TAP block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Jul 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.
When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.
Detailed description
This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Drug: Levobupivacaine Hydrochloride 2.5 MG/MLTransverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side. The patient receives usual analgesia protocol. |
| local infiltration of the trocar wounds | Active comparator | Drug: Levobupivacaine Hydrochloride 2.5 MG/MLlocal infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening. The patient receives usual analgesia protocol. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age betwween 3 and 15 years
- Weight < or = 50 kg
- indicaction of coelioscopic appendicectomy
- ASA 1,2 or 3
- consent of the children and the holder of parental autority
Key exclusion criteria (9 listed)
- Age<3 years or > 15years or weight > 50kg
- refusal of the children and the holder of parental autority
- ASA 4
- Peritonitis
- Patients with long term morphinic traitment
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 |
|---|---|---|
| Levobupivacaine Hydrochloride 2.5 MG/MLTo compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children | Drug | TAP Block, local infiltration of the trocar wounds |
Primary outcome
cumulative dose of nalbuphine in the 24 first hours post surgery
Time frame: 24 hours
recording in mg/kg
9 secondary outcomes
cumulative dose of nalbuphine H0-H12 post surgery
Time frame: from beginning to 12th hour
cumulative dose of nalbuphine H13-H24 post surgery
Time frame: From 13th hour to 24th hour
FLACC analgesia score at H1 H2 H6 H12 H24
Time frame: FLACC score will be performed from awakenig to 24 hours post surgery
FLACC score mean
Time frame: FLACC score will be performed from awakenig to 24 hours surgery
individual variations of FLACC score
Time frame: FLACC score will be performed from awakenig to 24 hours surgery
timing of first injection of nalbuphine
Time frame: in the first 24 post operative hours
incidence of post operative nausea and vomiting
Time frame: in the first 24 post operative hours
timing of first standing up
Time frame: in the first 24 post operative hours
adverse events
Time frame: in the first 24 post operative 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 23 Apr 2025.
- Derived from this study: PubMed 41777031Bloy G, Jurine A, Pili-Floury S, Auber F, Hild O, Guinot PG, Bouhemad B, Francois M, Vettoretti L, Bronnert R, Nguyen M, Chaussy Y, Besch G. Clinical effectiveness of transversus abdominis plane block versus local anaesthesia wound infiltration for postoperative pain relief after laparoscopic appendicectomy in children: A multicentre, double-blind, randomised, controlled phase III trial. Eur J Anaesthesiol. 2026 Mar 4. doi: 10.1097/EJA.0000000000002367. Online ahead of print.
- 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 Levobupivacaine Hydrochloride 2.5 MG/ML in people with Appendicitis Acute and Pediatrics, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 23 Apr 2025. 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 France. 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?
cumulative dose of nalbuphine in the 24 first hours post surgery (time frame: 24 hours). 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 NCT04969133, 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 23 Apr 2025.