Laparoscopic AppendectomyNCT02505841
Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children
A study testing TAP block with Ropivacaine and Curare in people with Laparoscopic Appendectomy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Laparoscopic Appendectomy
- What is being tested?
- TAP block with Ropivacaine and Curare
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Jun 2017
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient hospitalized in surgery and infantile anesthesia unit or admitted in emergencies for an laparoscopic appendectomy surgery.
- Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to II
- Patient member in a national insurance scheme
Who cannot join
- Patient with drilled appendicitis or peritonitis
- Patient with a contraindication to local anesthesics
- Patient with a contraindication to TAP block
- Patient with allergies or known hypersensitivity to curare
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization
The transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate its analgesic efficacy over the first 24 post operative hours.
- Conditions
- Laparoscopic Appendectomy
- Being tested
- TAP block with Ropivacaine, Curare
- Keywords
- Appendectomy, Laparoscopy, pediatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block with RopivacaineOther
Also called Transversus abdominis plane (TAP) block with ropivacaine
Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
CurareDrug
Also called Succinylcholine
Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Curare: Atracurium injection at 0.5 mg/kg Receives: Drug: Curare |
| Group 2 | Experimental | TAP block and curare: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg then atracurium injection at 0.5 mg/kg Receives: Other: TAP block with Ropivacaine; Drug: Curare |
| Group 3 | Experimental | TAP block: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg Receives: Other: TAP block with Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painkiller of help consumption
Quantity of analgesic of help (Nalbuphine, Nubain®, Dupont Pharma, Paris, France) taken after the surgery.
Measured: up to 24 hours after surgery
Secondary outcomes (2)
Pain intensity after surgery
The post-operative pain will be estimated from the arrival in recovery room with the Face Legs Activity Cry Consolability (FLACC) scale.
Measured: up to 24 hours
First demand of analgesic of help
First demand of analgesic of help (Nubain ®) after the surgery
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic AppendectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud MM Maniora, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505841
- Sponsor's protocol ID
- 9488
- Other IDs
- 2014-A01431-46
- Status last verified
- May 2015
- First submitted
- 22 Jun 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization
- ClinicalTrials.gov ID
- NCT02505841
- Acronym / sponsor ID
- 9488
- Conditions
- Laparoscopic Appendectomy
- Keywords
- Appendectomy, Laparoscopy, pediatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- 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 transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate its analgesic efficacy over the first 24 post operative hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: CurareCurare: Atracurium injection at 0.5 mg/kg |
| Group 2 | Experimental | Other: TAP block with Ropivacaine, Drug: CurareTAP block and curare: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg then atracurium injection at 0.5 mg/kg |
| Group 3 | Experimental | Other: TAP block with RopivacaineTAP block: Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient hospitalized in surgery and infantile anesthesia unit or admitted in emergencies for an laparoscopic appendectomy surgery.
- Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to II
- Patient member in a national insurance scheme
Key exclusion criteria (4 listed)
- Patient with drilled appendicitis or peritonitis
- Patient with a contraindication to local anesthesics
- Patient with a contraindication to TAP block
- Patient with allergies or known hypersensitivity to curare
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 |
|---|---|---|
| TAP block with RopivacaineAlso: Transversus abdominis plane (TAP) block with ropivacaineUltrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg | Other | Group 2, Group 3 |
| CurareAlso: SuccinylcholineAtracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision | Drug | Group 1, Group 2 |
Primary outcome
Painkiller of help consumption
Time frame: up to 24 hours after surgery
Quantity of analgesic of help (Nalbuphine, Nubain®, Dupont Pharma, Paris, France) taken after the surgery.
2 secondary outcomes
Pain intensity after surgery
Time frame: up to 24 hours
First demand of analgesic of help
Time frame: up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Related trials for Laparoscopic Appendectomy
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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.
Maud MM Maniora, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block with Ropivacaine and Curare in people with Laparoscopic Appendectomy, run by University Hospital, Montpellier 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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2015. 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?
Results are not available in the source record.
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?
Painkiller of help consumption (time frame: up to 24 hours 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 Jul 2015.