Epidural AnesthesiaNCT04222192
Different Type Ultrasound Guided Epidural Block Methods
A study testing Epidural block in people with Epidural Anesthesia and Ultrasound, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The nerve blocks applied with ultrasonography are used for pain and operation after many operations today. Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Epidural Anesthesia, Ultrasound
- What is being tested?
- Epidural block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 30 Jan 2021
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Patients whom need medical epidural anesthesia
- Patients with consent to participate in the study
Who cannot join
- Patients with a known history of back surgery
- Bleeding diathesis disorder
- Allergy to local anesthetics
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View
The nerve blocks applied with ultrasonography are used for pain and operation after many operations today.
Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.
However, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.
Read the detailed description
In this study the investigators will used the two different ultrasound -guided epidural block approach .
Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.
- Conditions
- Epidural Anesthesia, Ultrasound
- Being tested
- Epidural block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural blockOther
Epidural catheter insertions
| Study group | Role | What they receive |
|---|---|---|
| Conventional Epidural application | Sham comparator | Epidural catheter insertions with conventional (anatomical landmarks use) method Receives: Other: Epidural block |
| Paramedian sagittal application | Active comparator | Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach Receives: Other: Epidural block |
| Transverse Interlaminar application | Active comparator | Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach Receives: Other: Epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle routing
number of needle redirects forming successful block
Measured: 20 minutes
Epidural catheter placement time
time (minutes) until the epidural catheter is inserted
Measured: 20 minutes
Secondary outcomes (4)
Epidural igne visibility degree
4 = Excellent visibility, 3 = Medium visibility, 2 = Weak visibility 1 = No visibility using a 4-point Likert scale by the practitioner
Measured: 20 minutes
Difficulty of catheter placement
Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)
Measured: 30 minutes
distance measurement of neuraxial structures
Anterior and posterior complex distance measured during epidural administration.
Distance from skin to anterior aspect of ligament flavum (cm)
Distance from skin to posterior dura (cm)
Measured: 30 minutes
Patient position
Patient position during epidural placement Sitting Lateral
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start15 Jan 2020
- Primary completion15 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Assoc. PhD., Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222192
- Sponsor's protocol ID
- 2011-KAEK-25 2019/12-09
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View
- ClinicalTrials.gov ID
- NCT04222192
- Acronym / sponsor ID
- 2011-KAEK-25 2019/12-09
- Conditions
- Epidural Anesthesia, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 9 Jan 2020 (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 nerve blocks applied with ultrasonography are used for pain and operation after many operations today.
Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.
However, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.
Detailed description
In this study the investigators will used the two different ultrasound -guided epidural block approach .
Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Epidural application | Sham comparator | Other: Epidural blockEpidural catheter insertions with conventional (anatomical landmarks use) method |
| Paramedian sagittal application | Active comparator | Other: Epidural blockEpidural catheter insertions with real time ultrasound guided Paramedian sagittal approach |
| Transverse Interlaminar application | Active comparator | Other: Epidural blockEpidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Patients whom need medical epidural anesthesia
- Patients with consent to participate in the study
Key exclusion criteria (4 listed)
- Patients with a known history of back surgery
- Bleeding diathesis disorder
- Allergy to local anesthetics
- Patient refusal
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 |
|---|---|---|
| Epidural blockEpidural catheter insertions | Other | Conventional Epidural application, Paramedian sagittal application, Transverse Interlaminar application |
Primary outcome
Number of needle routing
Time frame: 20 minutes
number of needle redirects forming successful block
Epidural catheter placement time
Time frame: 20 minutes
time (minutes) until the epidural catheter is inserted
4 secondary outcomes
Epidural igne visibility degree
Time frame: 20 minutes
Difficulty of catheter placement
Time frame: 30 minutes
distance measurement of neuraxial structures
Time frame: 30 minutes
Patient position
Time frame: 20 minutes
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 23 Dec 2022.
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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.
Korgün Ökmen, Assoc. PhD. principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural block in people with Epidural Anesthesia and Ultrasound, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 4 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 23 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
Number of needle routing (time frame: 20 minutes). 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 Dec 2022.