Transversus Abdominis Plane BlockNCT04202367
The Efficacy of Different Bupivacaine Concentrations in Pediatric Patients Undergoing Transversus Abdominis Plane Block
A study testing 1 mg.kg-1 bupivacaine 0.25% and 1 mg.kg-1 bupivacaine 0.125% in people with Transversus Abdominis Plane Block, run by Istanbul University.
Trial summary
This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (TAP) block for unilateral inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Transversus Abdominis Plane Block
- What is being tested?
- 1 mg.kg-1 bupivacaine 0.25% and 1 mg.kg-1 bupivacaine 0.125%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Jul 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) status I/II
- Children between 1 to 8 years of age
- Patients undergoing unilateral inguinal hernia repair surgery
Who cannot join
- Denial of parents
- Patients who are allergic to local anesthetics
About this study
Official title: Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study
This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (TAP) block for unilateral inguinal hernia repair. In recruited 74 patients; Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
Read the detailed description
Transversus abdominis plane (TAP) block is a safe and effective analgesia technique for paediatric patients. This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in paediatric patients undergoing ultrasound-guided TAP blocks for unilateral inguinal hernia repair surgery. Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled for this study after obtaining Institutional Ethics Committee approval and written informed consents from parents or legal guardians (2016/1281). Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
- Conditions
- Transversus Abdominis Plane Block
- Being tested
- 1 mg.kg-1 bupivacaine 0.25%, 1 mg.kg-1 bupivacaine 0.125%
- Keywords
- Transversus abdominis plane block, Bupivacaine, Concentration, Postoperative analgesia, Inguinal hernia repair surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg.kg-1 bupivacaine 0.25%Drug
Also called Marcaine
Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.
1 mg.kg-1 bupivacaine 0.125%Drug
Also called Marcaine
Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.
| Study group | Role | What they receive |
|---|---|---|
| TAP block with 1 mg.kg-1 bupivacaine 0.25% | Active comparator | Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block Receives: Drug: 1 mg.kg-1 bupivacaine 0.25% |
| TAP block with 1 mg.kg-1 bupivacaine 0.125% | Active comparator | Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block Receives: Drug: 1 mg.kg-1 bupivacaine 0.125% |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC pediatric pain scores
It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.
Measured: up to 24 hours
Secondary outcomes (5)
Total analgesic requirement
Tramadol
Measured: up to 24 hours
First analgesic requirement time
Duration of postoperative analgesia
Measured: up to 24 hours
Incidence of side effects
Nausea, vomiting, respiratory depression
Measured: up to 24 hours
The length of hospital stay
Hospitalisation hours
Measured: up to 24 hours
Incidence of complications
Hemotoma, infection
Measured: up to first week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Nov 2016
- Primary completion1 Jun 2017
- Study completion1 Jul 2017
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 Transversus Abdominis Plane BlockStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ultrasound-guided TAP block was applied following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Assoc. Prof, Principal investigator, Istanbul UniversityEmine Aysu Salviz, Assoc. Prof, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202367
- Sponsor's protocol ID
- 2016/1281
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karadeniz MS, Atasever AG, Salviz EA, Bingul ES, Ciftci HS, Dincer MB, Sungur MO. Transversus abdominis plane block with different bupivacaine concentrations in children undergoing unilateral inguinal hernia repair: a single-blind randomized clinical trial. BMC Anesthesiol. 2022 Nov 21;22(1):355. doi: 10.1186/s12871-022-01907-y.
PubMed 36411426
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block With Different Bupivacaine Concentrations in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair Surgery: A Prospective Randomised Double-Blinded Study
- ClinicalTrials.gov ID
- NCT04202367
- Acronym / sponsor ID
- 2016/1281
- Conditions
- Transversus Abdominis Plane Block
- Keywords
- Transversus abdominis plane block, Bupivacaine, Concentration, Postoperative analgesia, Inguinal hernia repair surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 17 Dec 2019 (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 study is designed to compare the analgesic efficacy of different bupivacaine concentrations in pediatric patients undergoing ultrasound-guided transversus abdominis plane (TAP) block for unilateral inguinal hernia repair. In recruited 74 patients; Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
Detailed description
Transversus abdominis plane (TAP) block is a safe and effective analgesia technique for paediatric patients. This study is designed to compare the analgesic efficacy of different bupivacaine concentrations in paediatric patients undergoing ultrasound-guided TAP blocks for unilateral inguinal hernia repair surgery. Seventy-four patients aging between 1 and 8 years, undergoing unilateral inguinal hernia surgery, were enrolled for this study after obtaining Institutional Ethics Committee approval and written informed consents from parents or legal guardians (2016/1281). Group 1 (n:37) received 1 mg/kg bupivakain 0.25% and Group 2 (n: 37) received 1 mg/kg bupivakain 0.125% for ultrasound-guided TAP block following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively. FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain assessment scale was used for evaluating patients' postoperative pain levels at 15-, 30-, 45-minute and 1-, 2-, 6-, 24-hour. Tramadol 1 mg/kg was administered intravenously as rescue analgesic when FLACC score was ≥4. Total analgesic requirement, length of hospital stay and side effects were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Ultrasound-guided TAP block was applied following standard general anaesthesia induction. All patients received remifentanil 0,1 μg/kg/h infusion and paracetamol 15 mg/kg intraoperatively, and paracetamol 4x15 mg/kg per day postoperatively.
| Arm | Type | Receives |
|---|---|---|
| TAP block with 1 mg.kg-1 bupivacaine 0.25% | Active comparator | Drug: 1 mg.kg-1 bupivacaine 0.25%Patients had 1 mg.kg-1 bupivacaine 0.25% with US-guided TAP block |
| TAP block with 1 mg.kg-1 bupivacaine 0.125% | Active comparator | Drug: 1 mg.kg-1 bupivacaine 0.125%Patients had 1 mg.kg-1 bupivacaine 0.125% with US-guided TAP block |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) status I/II
- Children between 1 to 8 years of age
- Patients undergoing unilateral inguinal hernia repair surgery
Key exclusion criteria (2 listed)
- Denial of parents
- Patients who are allergic to local anesthetics
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 |
|---|---|---|
| 1 mg.kg-1 bupivacaine 0.25%Also: MarcaineUltrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery. | Drug | TAP block with 1 mg.kg-1 bupivacaine 0.25% |
| 1 mg.kg-1 bupivacaine 0.125%Also: MarcaineUltrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery. | Drug | TAP block with 1 mg.kg-1 bupivacaine 0.125% |
Primary outcome
FLACC pediatric pain scores
Time frame: up to 24 hours
It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0-10.
5 secondary outcomes
Total analgesic requirement
Time frame: up to 24 hours
First analgesic requirement time
Time frame: up to 24 hours
Incidence of side effects
Time frame: up to 24 hours
The length of hospital stay
Time frame: up to 24 hours
Incidence of complications
Time frame: up to first week.
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 17 Dec 2019.
- Derived from this study: PubMed 36411426Karadeniz MS, Atasever AG, Salviz EA, Bingul ES, Ciftci HS, Dincer MB, Sungur MO. Transversus abdominis plane block with different bupivacaine concentrations in children undergoing unilateral inguinal hernia repair: a single-blind randomized clinical trial. BMC Anesthesiol. 2022 Nov 21;22(1):355. doi: 10.1186/s12871-022-01907-y.
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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.
Meltem Savran Karadeniz, Assoc. Prof principal investigator
Istanbul University
Emine Aysu Salviz, Assoc. Prof study chair
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing 1 mg.kg-1 bupivacaine 0.25% and 1 mg.kg-1 bupivacaine 0.125% in people with Transversus Abdominis Plane Block, run by Istanbul 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 3 inclusion and 2 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 17 Dec 2019. 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.
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?
FLACC pediatric pain scores (time frame: up to 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 NCT04202367, 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 Dec 2019.