Inguinal or Ovarian HerniaTAP BlocNCT02064088
Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?
A study testing Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group and Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group in people with Inguinal or Ovarian Hernia and Hydrocele, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Inguinal or Ovarian Hernia, Hydrocele, Cord Kyst
- What is being tested?
- Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group and Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2015
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalisation in ambulatory surgery and anesthesia unit for surgery of inguinal hernia or ovarian hernia or hydrocele or cord kyst
- Overall status: ASA I-II
- Aged from 1 to 5 years
- Informed consent
Who cannot join
- Coagulation trouble
- Infection on ponction zone
- Local anesthesia drug or nonsteroidal anti inflammatory intolerance
- Cardiac/Renal/hepacticdysfunction
- Hemorrage, digestive perforation history
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34925
Chrystelle CS SOLA, MD, +33 665849166, c-sola@chu-montpellier.fr
Sophie SB BRINGUIER-BRANCHEREAU, PhD, +33 467338661, s-bringuierbranchereau@chu-montpellier.fr
About this study
Official title: Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety
The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.
- Conditions
- Inguinal or Ovarian Hernia, Hydrocele, Cord Kyst, Local Analgesia Block, One to Five Years
- Being tested
- Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group, Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group
- Keywords
- Regional anesthesia, TAP block, Pediatric anesthesia, analgesic effects, pharmacokinetics
- Medical subject headings
- Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume groupDrug
Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume groupDrug
Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
| Study group | Role | What they receive |
|---|---|---|
| Small volume | Experimental | Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine Receives: Drug: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group |
| High volume | Experimental | Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine Receives: Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit
Measured: from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery)
Secondary outcomes (8)
Intraoperative opioid consumption : total Rémifentanil (µg/kg)
Measured: for time of surgery (1 to 4 hours)
Post operative pain (FLACC scale) at hospital
Post operative pain is evaluated every 15 minutes in the recovery room and then every two hours in the ambulatory surgical unit until discharge at home.
Measured: from recovery room until discharge (An expected average of 4 hours after end of surgery)
Plasmatique peak of levobupivacaine (Cmax in µg/ml)
Measured: 5 min until 75 min after injection of local anaesthetic
Time necessary to reach plasmatique peak of levobupivacaine (tmax in min)
Measured: 5 min until 75 min after injection of local anaesthetic
Complications related to local analgesia procedure
cardiovascular adverse event, adverse vascular ponction (positive aspiration test for blood), adverse peritoneal ponction, hematoma
Measured: until 24 hours in post operative
First request of rescue antalgic (Nubain or Tramadol)
Measured: until 24 hours in post operative
Consommation of rescue antalgic
Measured: until 24 hours in post operative
Pain evaluation at home by parents (score PPMP)
Measured: call between 24 and 48 hours in post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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 Inguinal or Ovarian HerniaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle CS SOLA, MD, Principal investigator, CHU Montpellier - Lapeyronie Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064088
- Sponsor's protocol ID
- UF9206
- Acronym
- TAP Bloc
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sola C, Menace C, Bringuier S, Saour AC, Raux O, Mathieu O, Capdevila X, Dadure C. Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile. Anesth Analg. 2019 Jun;128(6):1234-1241. doi: 10.1213/ANE.0000000000003736.
PubMed 31094793
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety
- ClinicalTrials.gov ID
- NCT02064088
- Acronym / sponsor ID
- TAP Bloc / UF9206
- Conditions
- Inguinal or Ovarian Hernia, Hydrocele, Cord Kyst, Local Analgesia Block, One to Five Years
- Keywords
- Regional anesthesia, TAP block, Pediatric anesthesia, analgesic effects, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 17 Feb 2014 (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 provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small volume | Experimental | Drug: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume groupLocal analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine |
| High volume | Experimental | Drug: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume groupLocal analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hospitalisation in ambulatory surgery and anesthesia unit for surgery of inguinal hernia or ovarian hernia or hydrocele or cord kyst
- Overall status: ASA I-II
- Aged from 1 to 5 years
- Informed consent
Key exclusion criteria (5 listed)
- Coagulation trouble
- Infection on ponction zone
- Local anesthesia drug or nonsteroidal anti inflammatory intolerance
- Cardiac/Renal/hepacticdysfunction
- Hemorrage, digestive perforation history
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 |
|---|---|---|
| Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume groupUltrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles | Drug | Small volume |
| Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume groupUltrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles | Drug | High volume |
Primary outcome
number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit
Time frame: from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery)
8 secondary outcomes
Intraoperative opioid consumption : total Rémifentanil (µg/kg)
Time frame: for time of surgery (1 to 4 hours)
Post operative pain (FLACC scale) at hospital
Time frame: from recovery room until discharge (An expected average of 4 hours after end of surgery)
Plasmatique peak of levobupivacaine (Cmax in µg/ml)
Time frame: 5 min until 75 min after injection of local anaesthetic
Time necessary to reach plasmatique peak of levobupivacaine (tmax in min)
Time frame: 5 min until 75 min after injection of local anaesthetic
Complications related to local analgesia procedure
Time frame: until 24 hours in post operative
First request of rescue antalgic (Nubain or Tramadol)
Time frame: until 24 hours in post operative
Consommation of rescue antalgic
Time frame: until 24 hours in post operative
Pain evaluation at home by parents (score PPMP)
Time frame: call between 24 and 48 hours in post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Derived from this study: PubMed 31094793Sola C, Menace C, Bringuier S, Saour AC, Raux O, Mathieu O, Capdevila X, Dadure C. Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile. Anesth Analg. 2019 Jun;128(6):1234-1241. doi: 10.1213/ANE.0000000000003736.
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.
Chrystelle CS SOLA, MD principal investigator
CHU Montpellier - Lapeyronie Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group and Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group in people with Inguinal or Ovarian Hernia and Hydrocele, 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 4 inclusion and 5 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 17 Feb 2014. 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?
Contact Chrystelle CS SOLA, MD (+33 665849166, c-sola@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit (time frame: from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery)). 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 NCT02064088, 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 17 Feb 2014.