Anesthesia, CaudalNCT04590027
Caudal Block Versus Local Wound Infiltration for Inguinal Procedures
An observational study of Anesthesia, Caudal, run by University Hospital Tuebingen.
Trial summary
Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration Read more about this study
- Who is it for?
- Ages 3 to 68 months
- Conditions the study is for
- Anesthesia, Caudal
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 30 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 68 months
- All sexes
- No healthy volunteers
- Child
Study population: outpatient setting paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of paediatric surgery
Who may be able to join
- -
Who cannot join
- no return of questionnaire
- parents do not understand language
About this study
Official title: Caudal Block Versus Local Wound Infiltration for Inguinal Procedures in Young Children. A Prospective Observational Trial
Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration
Read the detailed description
Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .
Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.
- Conditions
- Anesthesia, Caudal
- Keywords
- caudal block, wound infiltration, postoperative pain, outpatient surgery
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Analgesia Quality Between the Two Groups
Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management
Measured: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,
Secondary outcomes (3)
Set up Time
How much times goes by for induction of anesthesia in both groups
Measured: Time in minutes measured between start of induction of anesthesia to start of surgical incision
Rescue Medication
total number of analgesic doses across all participants
Measured: 24 hours
Neurological Outcome
Time until first micturation an time to motor activity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2014
- Primary completion30 Jun 2015
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia, CaudalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590027
- Sponsor's protocol ID
- 621/2013BO1
- Status last verified
- Aug 2020
- First submitted
- 16 Sep 2020
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Block Versus Local Wound Infiltration for Inguinal Procedures in Young Children. A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT04590027
- Acronym / sponsor ID
- 621/2013BO1
- Conditions
- Anesthesia, Caudal
- Keywords
- caudal block, wound infiltration, postoperative pain, outpatient surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration
Detailed description
Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .
Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 68 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- outpatient setting paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of paediatric surgery
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- no return of questionnaire
- parents do not understand language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Analgesia Quality Between the Two Groups
Time frame: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,
Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management
3 secondary outcomes
Set up Time
Time frame: Time in minutes measured between start of induction of anesthesia to start of surgical incision
Rescue Medication
Time frame: 24 hours
Neurological Outcome
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Caudal, run by University Hospital Tuebingen.
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 1 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 14 Jul 2021. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Analgesia Quality Between the Two Groups (time frame: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,). 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 14 Jul 2021.