Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D000081282NCT04990635
Evaluation of Caudal Block Success With Perfusion Index
An observational study of Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D000081282, run by MEHMET DURAN at 1 site in Turkey (Türkiye).
Trial summary
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use started to become widespread after the 1960s(1). The procedure is safe, easy to apply, has a low incidence of complications, and the total complication rate is 1.5/1000; serious complications are 1/40000 (2,3). Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D000081282
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2021to 30 Sep 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: PATIENT GROUP BETWEEN 1 YEARS OLD AND 6 YEARS OLD WITH INGUINAL HERNI, HYPOSPADIAS, NON-DESCENDED TESTIC SURGERY
Who may be able to join
- lower abdomen/urogenital/lower extremity surgery
- PEDIATRIC GROUP BETWEEN 1-6 YEARS
- Patients with ASA1-2
Who cannot join
- Neuromuscular disease
- PATIENTS WITH ASA3-4
- Patients with cerebral palsy
- Patients with mental retardation
- Patients with hematological disorders
- Infection in the region to be caudal block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Correlation of Block Success With Perfusion Index Measurement in Pediatric Surgery Performed Under Caudal Epidural Block Anesthesia"
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use started to become widespread after the 1960s(1). The procedure is safe, easy to apply, has a low incidence of complications, and the total complication rate is 1.5/1000; serious complications are 1/40000 (2,3). There are many methods to demonstrate the success of caudal epidural block. Some of the usual traditional methods are changes in mean arterial pressure, heart rate and cremasteric reflex. These methods are sometimes not objective, but take time. In this study, we will examine whether the success of the block in pediatric patients who underwent caudal epidural block, which is applied in our hospital, is correlated with the success of the block, measured with the finger probe, other than traditional methods, and whether the perfusion index shows faster block success than other traditional methods.
Read the detailed description
A successful caudal epidural block can provide safe, effective regional anesthesia(4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4% according to the anatomical and developmental abnormalities of the caudal canal(1,5). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of the caudal epidural block with traditional methods such as mean arterial pressure(MAP), heart rate and cremaster reflex is completely objective.
The aim of this study is to evaluate whether it will detect the success of caudal epidural block faster than other traditional methods in pediatric patients who underwent surgery with caudal epidural block, using perfusion index values measured with a finger probe.
This research; It is a prospective observational study. In our pediatric patients who routinely underwent caudal epidural block under sedation in our hospital, perfusion index values will be recorded by attaching a probe to the big toe. Perfusion index(PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow.(6) PI works by measuring the changes in finger peripheral perfusion through pulse oximetry.(7) If the procedure is successful in patients who underwent caudal epidural block, there is an increase in perfusion in the lower extremities due to sympathetic nerve blockade. Therefore, in our study, we will observe whether perfusion increases by measuring the perfusion index value measured using a finger probe, by attaching the probe to the big toe, before the caudal epidural block is performed and at the 1,5, 7, 10, 15 and 20 minutes after the caudal epidural block. Simultaneously, the mean arterial pressure, heart rate and changes will be recorded by looking at the cremaster reflex in male patients. The finding that shows the presence of the cremaster reflex is to hit the upper inner part of the thigh and to pull the scrotum and testis on the same side. A 15% decrease in pulse rate and an increase in the perfusion index value indicate a successful caudal epidural block. We will examine whether the increase in the perfusion index after these procedures is correlated with the success of the block, and whether the perfusion index shows a faster block success than other traditional methods.
- Keywords
- PERFUSION INDEX, PEDIATRIC CAUDAL BLOCK
What is being measured
The primary outcome is the main question the study is designed to answer.
DISPLAYING CAUDAL BLOCK SUCCESS BY PERFUSION INDEX IN PEDIATRIC PATIENT GROUP
CORRELATION OF CAUDAL BLOCK SUCCESS WITH PERFUSION INDEX VALUE WILL BE EVALUATED APPLICABLE TO SEDATATIZED PEDIATRIC PATIENTS IN LOWER ABONE SURGERIES
Measured: PATIENTS PIERFUSION INDEX, PULSE AND TENSION MEASUREMENTS 1.5,7,10,15,20 MINUTES AFTER THE CAUDAL BLOCK IS MADE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Aug 2021 (estimated)
- Primary completion18 Aug 2021
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D000081282Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- MEHMET DURAN
- Sponsor type
- University, hospital or other
- Collaborators
- CDemirci
- Responsible party
- Sponsor-investigator, MEHMET DURAN, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990635
- Sponsor's protocol ID
- 2020/8-25
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
PubMed 16682915Markakis DA. Regional anesthesia in pediatrics. Anesthesiol Clin North Am. 2000 Jun;18(2):355-81, vii. doi: 10.1016/s0889-8537(05)70168-1.
PubMed 10935015Sanders JC. Paediatric regional anaesthesia, a survey of practice in the United Kingdom. Br J Anaesth. 2002 Nov;89(5):707-10.
PubMed 12393767Seyedhejazi M, Taheri R, Ghojazadeh M. The evaluation of upper leg traction in lateral position for pediatric caudal block. Saudi J Anaesth. 2011 Jul;5(3):248-51. doi: 10.4103/1658-354X.84096.
PubMed 21957401Dalens B, Hasnaoui A. Caudal anesthesia in pediatric surgery: success rate and adverse effects in 750 consecutive patients. Anesth Analg. 1989 Feb;68(2):83-9.
PubMed 2913854Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
PubMed 12580205Huang HS, Chu CL, Tsai CT, Wu CK, Lai LP, Yeh HM. Perfusion index derived from a pulse oximeter can detect changes in peripheral microcirculation during uretero-renal-scopy stone manipulation (URS-SM). PLoS One. 2014 Dec 26;9(12):e115743. doi: 10.1371/journal.pone.0115743. eCollection 2014.
PubMed 25542000
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation of Block Success With Perfusion Index Measurement in Pediatric Surgery Performed Under Caudal Epidural Block Anesthesia"
- ClinicalTrials.gov ID
- NCT04990635
- Acronym / sponsor ID
- 2020/8-25
- Keywords
- PERFUSION INDEX, PEDIATRIC CAUDAL BLOCK
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- MEHMET DURANUniversity, hospital or other
- Collaborators
- CDemirci
- Study start
- 17 Aug 2021 (estimated)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Aug 2021 (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.
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use started to become widespread after the 1960s(1). The procedure is safe, easy to apply, has a low incidence of complications, and the total complication rate is 1.5/1000; serious complications are 1/40000 (2,3). There are many methods to demonstrate the success of caudal epidural block. Some of the usual traditional methods are changes in mean arterial pressure, heart rate and cremasteric reflex. These methods are sometimes not objective, but take time. In this study, we will examine whether the success of the block in pediatric patients who underwent caudal epidural block, which is applied in our hospital, is correlated with the success of the block, measured with the finger probe, other than traditional methods, and whether the perfusion index shows faster block success than other traditional methods.
Detailed description
A successful caudal epidural block can provide safe, effective regional anesthesia(4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4% according to the anatomical and developmental abnormalities of the caudal canal(1,5). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of the caudal epidural block with traditional methods such as mean arterial pressure(MAP), heart rate and cremaster reflex is completely objective.
The aim of this study is to evaluate whether it will detect the success of caudal epidural block faster than other traditional methods in pediatric patients who underwent surgery with caudal epidural block, using perfusion index values measured with a finger probe.
This research; It is a prospective observational study. In our pediatric patients who routinely underwent caudal epidural block under sedation in our hospital, perfusion index values will be recorded by attaching a probe to the big toe. Perfusion index(PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow.(6) PI works by measuring the changes in finger peripheral perfusion through pulse oximetry.(7) If the procedure is successful in patients who underwent caudal epidural block, there is an increase in perfusion in the lower extremities due to sympathetic nerve blockade. Therefore, in our study, we will observe whether perfusion increases by measuring the perfusion index value measured using a finger probe, by attaching the probe to the big toe, before the caudal epidural block is performed and at the 1,5, 7, 10, 15 and 20 minutes after the caudal epidural block. Simultaneously, the mean arterial pressure, heart rate and changes will be recorded by looking at the cremaster reflex in male patients. The finding that shows the presence of the cremaster reflex is to hit the upper inner part of the thigh and to pull the scrotum and testis on the same side. A 15% decrease in pulse rate and an increase in the perfusion index value indicate a successful caudal epidural block. We will examine whether the increase in the perfusion index after these procedures is correlated with the success of the block, and whether the perfusion index shows a faster block success than other traditional methods.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PATIENT GROUP BETWEEN 1 YEARS OLD AND 6 YEARS OLD WITH INGUINAL HERNI, HYPOSPADIAS, NON-DESCENDED TESTIC SURGERY
Key inclusion criteria (3 listed)
- lower abdomen/urogenital/lower extremity surgery
- PEDIATRIC GROUP BETWEEN 1-6 YEARS
- Patients with ASA1-2
Key exclusion criteria (6 listed)
- Neuromuscular disease
- PATIENTS WITH ASA3-4
- Patients with cerebral palsy
- Patients with mental retardation
- Patients with hematological disorders
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
DISPLAYING CAUDAL BLOCK SUCCESS BY PERFUSION INDEX IN PEDIATRIC PATIENT GROUP
Time frame: PATIENTS PIERFUSION INDEX, PULSE AND TENSION MEASUREMENTS 1.5,7,10,15,20 MINUTES AFTER THE CAUDAL BLOCK IS MADE
CORRELATION OF CAUDAL BLOCK SUCCESS WITH PERFUSION INDEX VALUE WILL BE EVALUATED APPLICABLE TO SEDATATIZED PEDIATRIC PATIENTS IN LOWER ABONE SURGERIES
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 16682915Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
- Background: PubMed 10935015Markakis DA. Regional anesthesia in pediatrics. Anesthesiol Clin North Am. 2000 Jun;18(2):355-81, vii. doi: 10.1016/s0889-8537(05)70168-1.
- Background: PubMed 12393767Sanders JC. Paediatric regional anaesthesia, a survey of practice in the United Kingdom. Br J Anaesth. 2002 Nov;89(5):707-10.
- Background: PubMed 21957401Seyedhejazi M, Taheri R, Ghojazadeh M. The evaluation of upper leg traction in lateral position for pediatric caudal block. Saudi J Anaesth. 2011 Jul;5(3):248-51. doi: 10.4103/1658-354X.84096.
- Background: PubMed 2913854Dalens B, Hasnaoui A. Caudal anesthesia in pediatric surgery: success rate and adverse effects in 750 consecutive patients. Anesth Analg. 1989 Feb;68(2):83-9.
- Background: PubMed 12580205Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
- Background: PubMed 25542000Huang HS, Chu CL, Tsai CT, Wu CK, Lai LP, Yeh HM. Perfusion index derived from a pulse oximeter can detect changes in peripheral microcirculation during uretero-renal-scopy stone manipulation (URS-SM). PLoS One. 2014 Dec 26;9(12):e115743. doi: 10.1371/journal.pone.0115743. eCollection 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D000081282, run by MEHMET DURAN 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 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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?
Results are not available in the source record.
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?
DISPLAYING CAUDAL BLOCK SUCCESS BY PERFUSION INDEX IN PEDIATRIC PATIENT GROUP (time frame: PATIENTS PIERFUSION INDEX, PULSE AND TENSION MEASUREMENTS 1.5,7,10,15,20 MINUTES AFTER THE CAUDAL BLOCK IS MADE). 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 NCT04990635, which also lists 7 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 18 Aug 2021.