Caudal Epidural BlockPhase 4NCT06695520
Perfusion Index in Caudal Epidural Anasthesia
A Phase 4 study testing Caudal epidural block in people with Caudal Epidural Block, run by Assiut University.
Trial summary
A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Caudal Epidural Block
- What is being tested?
- Caudal epidural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -ASA physical status I-II. -Both sexes -Age between 2 and 10 years -Patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.
Who cannot join
- ASA physical status more than II.
- Patients having any neurological disorders, bleeding disorder, bony deformity of vertebral column.
- infection at the injection site, drug allergy, and undergoing anal surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is The Perfusion Index An Indicator for Success of Caudal Epidural Anasthesia in Pediatric Patients?
A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects of intravenous opioid medication, like nausea and vomiting during emergence, cardiovascular, and respiratory depression. the aim of the study was to assess, perfusion index (PI) as an indicator for success of caudal block onset in pediatric patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.
with guidance of ultrasonography.
Read the detailed description
It is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space. Using conventional blind technique, the failure rate of caudal epidural block is high even in experienced hands. With the advent of ultrasound in guiding needle placement, the success rate of caudal epidural block has been markedly improved and could be effective in preventing complications during caudal epidural injection. After administration of a caudal block, reliable assessment of caudal block is very crucial to ascertain the success of block. The onset of caudal block is often assessed by cold stimuli and cutaneous temperature changes. Caudal block in pediatric patients is often performed under general anesthesia. Hence, testing the sensory levels by above techniques cannot be used. Also the change in the hemodynamic parameters are few other assessment methods. These methods are to be used 15-20 min after block administration, to confirm the efficacy of a caudal block. Perfusion index (PI), independent of parameters like heart rate, oxygen saturation of blood, or body temperature, measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value . PI is considered as a sensitive marker to assess the efficacy of caudal block. It can detect the onset of caudal block, by increasing PI beyond the pre-induction values, which can be due to the sympathectomy induced after successful caudal administration,which increases the blood flow to the peripheral tissues.
- Conditions
- Caudal Epidural Block
- Being tested
- Caudal epidural block
- Keywords
- Perfusion Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal epidural blockProcedure or surgery
Ultrasound Guidance: Using ultrasound improves the accuracy of the block by allowing real-time visualization of the anatomy and needle placement . injection: .5-1mg/kg of 25% bupivacaine according to the needed block level.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | patients will receive General Anesthesia and Caudal Epidural Anesthesia Receives: Procedure: Caudal epidural block |
| GROUP (B) | No intervention | patients will receive General Anesthesia only |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in perfusion index.
measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Caudal Epidural BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Samir Melad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695520
- Sponsor's protocol ID
- Perfusion Index
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buono RD, Pascarella G, Costa F, Agro FE. The perfusion index could early predict a nerve block success: A preliminary report. Saudi J Anaesth. 2020 Oct-Dec;14(4):442-445. doi: 10.4103/sja.SJA_171_20. Epub 2020 Sep 24.
PubMed 33447184Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.
PubMed 28337460Dave NM, Garasia M. A comparison of the effectiveness of predictors of caudal block in children-swoosh test, anal sphincter tone, and heart rate response. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):17-20. doi: 10.4103/0970-9185.92428.
PubMed 22345939Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.
PubMed 24174910
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is The Perfusion Index An Indicator for Success of Caudal Epidural Anasthesia in Pediatric Patients?
- ClinicalTrials.gov ID
- NCT06695520
- Acronym / sponsor ID
- Perfusion Index
- Conditions
- Caudal Epidural Block
- Keywords
- Perfusion Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Nov 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.
A caudal epidural block is among the most widely administered techniques of regional anesthesia in pediatric patients. It helps in reducing the intraoperative dose of inhalational anesthetic agent used for maintenance of anesthesia and in addition provides an excellent postoperative analgesia without the side effects of intravenous opioid medication, like nausea and vomiting during emergence, cardiovascular, and respiratory depression. the aim of the study was to assess, perfusion index (PI) as an indicator for success of caudal block onset in pediatric patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.
with guidance of ultrasonography.
Detailed description
It is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space. Using conventional blind technique, the failure rate of caudal epidural block is high even in experienced hands. With the advent of ultrasound in guiding needle placement, the success rate of caudal epidural block has been markedly improved and could be effective in preventing complications during caudal epidural injection. After administration of a caudal block, reliable assessment of caudal block is very crucial to ascertain the success of block. The onset of caudal block is often assessed by cold stimuli and cutaneous temperature changes. Caudal block in pediatric patients is often performed under general anesthesia. Hence, testing the sensory levels by above techniques cannot be used. Also the change in the hemodynamic parameters are few other assessment methods. These methods are to be used 15-20 min after block administration, to confirm the efficacy of a caudal block. Perfusion index (PI), independent of parameters like heart rate, oxygen saturation of blood, or body temperature, measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value . PI is considered as a sensitive marker to assess the efficacy of caudal block. It can detect the onset of caudal block, by increasing PI beyond the pre-induction values, which can be due to the sympathectomy induced after successful caudal administration,which increases the blood flow to the peripheral tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Procedure: Caudal epidural blockpatients will receive General Anesthesia and Caudal Epidural Anesthesia |
| GROUP (B) | No intervention | –patients will receive General Anesthesia only |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -ASA physical status I-II. -Both sexes -Age between 2 and 10 years -Patients scheduled for elective surgery of lower abdomen, pelvic region, genital region, or lower limbs.
Key exclusion criteria (3 listed)
- ASA physical status more than II.
- Patients having any neurological disorders, bleeding disorder, bony deformity of vertebral column.
- infection at the injection site, drug allergy, and undergoing anal surgery.
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 |
|---|---|---|
| Caudal epidural blockUltrasound Guidance: Using ultrasound improves the accuracy of the block by allowing real-time visualization of the anatomy and needle placement . injection: .5-1mg/kg of 25% bupivacaine according to the needed block level. | Procedure or surgery | Group (A) |
Primary outcome
changes in perfusion index.
Time frame: baseline
measures the ratio of arterial blood flow (pulsatile flow) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and it is shown in percentage or absolute value
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Results publication: PubMed 33447184Buono RD, Pascarella G, Costa F, Agro FE. The perfusion index could early predict a nerve block success: A preliminary report. Saudi J Anaesth. 2020 Oct-Dec;14(4):442-445. doi: 10.4103/sja.SJA_171_20. Epub 2020 Sep 24.
- Results publication: PubMed 28337460Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.
- Results publication: PubMed 22345939Dave NM, Garasia M. A comparison of the effectiveness of predictors of caudal block in children-swoosh test, anal sphincter tone, and heart rate response. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):17-20. doi: 10.4103/0970-9185.92428.
- Results publication: PubMed 24174910Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caudal epidural block in people with Caudal Epidural Block, run by Assiut 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Samir Melad Seha, resident doctor (+2 01111782409, Monica.16285820@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in perfusion index. (time frame: baseline). 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 NCT06695520, which also lists 4 linked publications.
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 19 Nov 2024.