AnesthesiaPhase 1/2CBvsLWINCT02620566
Caudal Block vs Local Wound Infiltration for Hernia Repair in Children
A Phase 1/2 study testing Bupivacain- Caudal and Bupivacaine- Local in people with Anesthesia, run by University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa at 1 site in North Macedonia.
Trial summary
To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or… Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Bupivacain- Caudal and Bupivacaine- Local
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- Sep 2015to Dec 2015
- Phase
- Phase 1/2
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 month to 7 years
- ASA physical status I or II
- undergoing unilateral hernia repair
Who cannot join
- history of developmental delay or mental retardation
- type I diabetes
- known or suspected coagulopathy
- known allergy to any local anesthetic
- known congenital anomaly of the spine
- signs of spinal anomaly or infection at the sacral or inguinal region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).
Read the detailed description
Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).
Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.
- Conditions
- Anesthesia
- Being tested
- Bupivacain- Caudal, Bupivacaine- Local
- Keywords
- caudal block, local wound infiltration, hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain- CaudalProcedure or surgery
Also called Caudal block
Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
Bupivacaine- LocalProcedure or surgery
Also called Local Wound Infiltration
Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
| Study group | Role | What they receive |
|---|---|---|
| Bupivacain -Caudal | Active comparator | Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%. Receives: Procedure: Bupivacain- Caudal |
| Bupivacain- Local | Active comparator | Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%. Receives: Procedure: Bupivacaine- Local |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Analgesic Requirement
The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative
Measured: 24 hours
Secondary outcomes (1)
The total number of oral acetaminophen
Total number of analgesic requirement
Measured: The number of analgesic received for the period of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Gavrilovska-Brzanov MD Msc., University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
- Investigators
- Aleksandra Gavrilovska-Brzanov, MD. Msc, Principal investigator, Mother Theresa University Clinical Center Skopje Macedonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620566
- Sponsor's protocol ID
- UCTOARICED1
- Acronym
- CBvsLWI
- Status last verified
- Jan 2016
- First submitted
- 20 Sep 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
- ClinicalTrials.gov ID
- NCT02620566
- Acronym / sponsor ID
- CBvsLWI / UCTOARICED1
- Conditions
- Anesthesia
- Keywords
- caudal block, local wound infiltration, hernia repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Clinic for Anesthesia Reanimation and Intensive Care Mother TheresaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Dec 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.
To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).
Detailed description
Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).
Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacain -Caudal | Active comparator | Procedure: Bupivacain- CaudalSingle shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%. |
| Bupivacain- Local | Active comparator | Procedure: Bupivacaine- LocalSingle shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 month to 7 years
- ASA physical status I or II
- undergoing unilateral hernia repair
Key exclusion criteria (6 listed)
- history of developmental delay or mental retardation
- type I diabetes
- known or suspected coagulopathy
- known allergy to any local anesthetic
- known congenital anomaly of the spine
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 |
|---|---|---|
| Bupivacain- CaudalAlso: Caudal blockBupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml). | Procedure or surgery | Bupivacain -Caudal |
| Bupivacaine- LocalAlso: Local Wound InfiltrationBupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml). | Procedure or surgery | Bupivacain- Local |
Primary outcome
Time to First Analgesic Requirement
Time frame: 24 hours
The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative
1 secondary outcome
The total number of oral acetaminophen
Time frame: The number of analgesic received for the period of 24 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 5 Jan 2016.
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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.
Aleksandra Gavrilovska-Brzanov, MD. Msc principal investigator
Mother Theresa University Clinical Center Skopje Macedonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupivacain- Caudal and Bupivacaine- Local in people with Anesthesia, run by University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa at 1 site in North Macedonia.
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 6 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 5 Jan 2016. 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 North Macedonia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to First Analgesic Requirement (time frame: 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 Jan 2016.