Pain, PostoperativePhase 4NCT02567487
TAP Block With Two Different Doses of Levobupivacaine
A Phase 4 study testing Levobupivacaine in people with Pain, Postoperative, run by Ankara University.
Trial summary
The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- Phase
- Phase 4
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
- Aged between 2 and 12
Who cannot join
- Patients with coagulation dysfunction
- Patients with chronic pain
- Patients having infection at the site of intervention
- Patients with a history of allergy
- Patients having chronic diseases (hepatic dysfunction, renal failure)
About this study
Official title: Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.
The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.
Read the detailed description
Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.
- Conditions
- Pain, Postoperative
- Being tested
- Levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine
Transversus abdominis plane block with levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group Levobupivacaine high volume | Active comparator | TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia Receives: Drug: Levobupivacaine |
| Group Levobupivacaine low volume | Active comparator | TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative VAS score <4 at postoperative 24 hours
Measured: Postoperative first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Uyar, Ankara University
- Investigators
- Neslihan Alkis, Study director, Ankara University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567487
- Sponsor's protocol ID
- 931893045140401
- Status last verified
- Oct 2015
- First submitted
- 17 Sep 2015
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02567487
- Acronym / sponsor ID
- 931893045140401
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 Oct 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 aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.
The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.
Detailed description
Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Levobupivacaine high volume | Active comparator | Drug: LevobupivacaineTAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia |
| Group Levobupivacaine low volume | Active comparator | Drug: LevobupivacaineTAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
- Aged between 2 and 12
Key exclusion criteria (5 listed)
- Patients with coagulation dysfunction
- Patients with chronic pain
- Patients having infection at the site of intervention
- Patients with a history of allergy
- Patients having chronic diseases (hepatic dysfunction, renal failure)
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 |
|---|---|---|
| LevobupivacaineAlso: ChirocaineTransversus abdominis plane block with levobupivacaine | Drug | Group Levobupivacaine high volume, Group Levobupivacaine low volume |
Primary outcome
postoperative VAS score <4 at postoperative 24 hours
Time frame: Postoperative first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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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.
Neslihan Alkis study director
Ankara University Medical Faculty
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Pain, Postoperative, run by Ankara University.
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 2 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative VAS score <4 at postoperative 24 hours (time frame: Postoperative first 24 hours). 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 5 Oct 2015.