Regional Anesthesia MorbidityNCT03368833
Caudal Blockade and Electrocardiographic Changes
An observational study of Regional Anesthesia Morbidity, run by Senthil G. Krishna at 1 site in United States.
Trial summary
Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Electrocardiogram
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 6 Sep 2022
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients having general surgery at Nationwide Children's Hospital.
Who may be able to join
- ASA grade 1 or 2
- Receiving general anesthesia with a caudal block
Who cannot join
- Preexisting cardiac comorbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Electrocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Also called ECG, EKG
12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Patients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care. Receives: Diagnostic Test: Electrocardiogram | |
| Control | Patients who do not receive a caudal block. Receives: Diagnostic Test: Electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in T wave amplitude
Change in T wave amplitude on the ECG tracings
Measured: Baseline to 60 mins. post caudal
Change in T wave width
Change in T wave width on the ECG tracings
Measured: Baseline to 60 mins. post caudal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start15 Dec 2017
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: Caudal blockade no longer being used in the ORs at this hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senthil G. Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senthil G. Krishna, Nationwide Children's Hospital
- Investigators
- Senthil Krishna, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368833
- Sponsor's protocol ID
- IRB17-00861
- Status last verified
- Feb 2023
- First submitted
- 28 Sep 2017
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Blockade and Electrocardiographic Changes
- ClinicalTrials.gov ID
- NCT03368833
- Acronym / sponsor ID
- IRB17-00861
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Caudal blockade no longer being used in the ORs at this hospital.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Senthil G. KrishnaUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 11 Dec 2017 (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 blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block | – | Diagnostic Test: ElectrocardiogramPatients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care. |
| Control | – | Diagnostic Test: ElectrocardiogramPatients who do not receive a caudal block. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients having general surgery at Nationwide Children's Hospital.
Key inclusion criteria (2 listed)
- ASA grade 1 or 2
- Receiving general anesthesia with a caudal block
Key exclusion criteria (1 listed)
- Preexisting cardiac comorbidities
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 |
|---|---|---|
| ElectrocardiogramAlso: ECG, EKG12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block. | Diagnostic test | Caudal block, Control |
Primary outcome
Change in T wave amplitude
Time frame: Baseline to 60 mins. post caudal
Change in T wave amplitude on the ECG tracings
Change in T wave width
Time frame: Baseline to 60 mins. post caudal
Change in T wave width on the ECG tracings
Results and safety
The study was stopped early (reason given: Caudal blockade no longer being used in the ORs at this hospital.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Regional Anesthesia Morbidity
Recruiting
Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia
Regional Anesthesia, Regional Anesthesia Morbidity
Recruiting
Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries
Regional Anesthesia Morbidity, Supratentorial Brain Tumor
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Active, not recruitingObservational study
Retrospective Analysis of Pain After Nerve Block in Surgical Patients
Regional Anesthesia Morbidity, Acute Pain
Recruiting
Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial
Arthropathy of Hip, Hip Arthropathy
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.
Senthil Krishna, MD principal investigator
Nationwide Children's Hospital
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 Regional Anesthesia Morbidity, run by Senthil G. Krishna at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 23 Feb 2023. 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 United States. 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 was stopped early (reason given: Caudal blockade no longer being used in the ORs at this hospital.). 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?
Change in T wave amplitude (time frame: Baseline to 60 mins. post caudal). The study lists 2 primary outcomes in all. 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 23 Feb 2023.