Urogenital DiseasesSESPBNCT06373185
Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children
A study testing Ultrasound-guided sacral erector spinae plane block and Ultrasound-guided caudal block in people with Urogenital Diseases and Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Urogenital Diseases, Nerve Block, Pain, Postoperative
- What is being tested?
- Ultrasound-guided sacral erector spinae plane block and Ultrasound-guided caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 18 Jul 2024
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1-7 years undergoing paediatric urogenital surgery
- Patients in American Society of Anesthesiologist (ASA) class I-II
Who cannot join
- Patients whose parents do not give consent
- Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
- Patients with known local anaesthetic allergy
- Patients for whom regional anaesthesia is contraindicated
- Known neurological or muscular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Research and Training Hospital
Giresun, Central, 28100
About this study
Official title: Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases
The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.
Read the detailed description
The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.
- Conditions
- Urogenital Diseases, Nerve Block, Pain, Postoperative
- Being tested
- Ultrasound-guided sacral erector spinae plane block, Ultrasound-guided caudal block
- Keywords
- sacral erector spinae plane block, caudal block, nerve block, anesthesia, general, urogenital surgery
- Medical subject headings
- Urogenital Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided sacral erector spinae plane blockProcedure or surgery
Patients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management
Ultrasound-guided caudal blockProcedure or surgery
Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| SESPB | Experimental | Participants received ultrasound-guided SESPB before the surgery Receives: Procedure: Ultrasound-guided sacral erector spinae plane block |
| CAUDAL | Active comparator | Participants received ultrasound-guided caudal block before the surgery Receives: Procedure: Ultrasound-guided caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Leg, Activity, Cry, Consolability (FLACC) score
The FLACC is an observational pain scale. It is widely used in the paediatric population to assess pain in infants and children who are unable to verbally express their pain.Each category is scored on the 0-2 scale which results in a total score of 0-10.
Measured: baseline ,and 24 hours
Secondary outcomes (3)
Analgesic requirement
If the FLACC>4 and above rescue analgesics will be made
Measured: baseline, and 24 hours
Satisfaction of the patient's parents
A questionnaire will be used in which patient's parents will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied
Measured: 24. hours
Satisfaction of the surgeons
A questionnaire will be used in which surgeon's will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied
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 posted18 Apr 2024
- Study start22 Apr 2024
- Primary completion22 Jun 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urogenital DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Olgun Keles, Giresun University
- Investigators
- Bilge Olgun Keleş, Principal investigator, Giresun UniversityDilek Yeniay, Study chair, Giresun UniversityElvan Tekir Yılmaz, Study chair, Giresun Universityİlke Tamdoğan, Study chair, Giresun UniversityMehmet Değermenci, Study chair, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373185
- Sponsor's protocol ID
- 2023/21
- Acronym
- SESPB
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases
- ClinicalTrials.gov ID
- NCT06373185
- Acronym / sponsor ID
- SESPB / 2023/21
- Conditions
- Urogenital Diseases, Nerve Block, Pain, Postoperative
- Keywords
- sacral erector spinae plane block, caudal block, nerve block, anesthesia, general, urogenital surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 18 Apr 2024 (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.
The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.
Detailed description
The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled double blind study
| Arm | Type | Receives |
|---|---|---|
| SESPB | Experimental | Procedure: Ultrasound-guided sacral erector spinae plane blockParticipants received ultrasound-guided SESPB before the surgery |
| CAUDAL | Active comparator | Procedure: Ultrasound-guided caudal blockParticipants received ultrasound-guided caudal block before the surgery |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 1-7 years undergoing paediatric urogenital surgery
- Patients in American Society of Anesthesiologist (ASA) class I-II
Key exclusion criteria (5 listed)
- Patients whose parents do not give consent
- Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
- Patients with known local anaesthetic allergy
- Patients for whom regional anaesthesia is contraindicated
- Known neurological or muscular disease
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 |
|---|---|---|
| Ultrasound-guided sacral erector spinae plane blockPatients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management | Procedure or surgery | SESPB |
| Ultrasound-guided caudal blockPatients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management | Procedure or surgery | CAUDAL |
Primary outcome
Face, Leg, Activity, Cry, Consolability (FLACC) score
Time frame: baseline ,and 24 hours
The FLACC is an observational pain scale. It is widely used in the paediatric population to assess pain in infants and children who are unable to verbally express their pain.Each category is scored on the 0-2 scale which results in a total score of 0-10.
3 secondary outcomes
Analgesic requirement
Time frame: baseline, and 24 hours
Satisfaction of the patient's parents
Time frame: 24. hours
Satisfaction of the surgeons
Time frame: 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 22 Jul 2024.
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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.
Bilge Olgun Keleş principal investigator
Giresun University
Dilek Yeniay study chair
Giresun University
Elvan Tekir Yılmaz study chair
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided sacral erector spinae plane block and Ultrasound-guided caudal block in people with Urogenital Diseases and Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 22 Jul 2024. 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 Turkey (Türkiye). 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?
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?
Face, Leg, Activity, Cry, Consolability (FLACC) score (time frame: baseline ,and 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 22 Jul 2024.