Regional Anesthesia MorbidityNCT03744520
Sensorial Block Assessment of Erector Spinae Block
A study testing Erector spinae plane block in people with Regional Anesthesia Morbidity, run by Onur Selvi at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 3 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who received successful erector spinae plane block for postoperative analgesia
Who cannot join
- Patients under 18 years old
- Patients who are not able to communicate with
- Patients who are on medication which may change the perception of pain.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University Medical Faculty
Istanbul, Maltepe, 34843
About this study
Official title: Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study
Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Erector spinae plane block
- Keywords
- regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Experimental | The patients who had paravertebral interfacial plane block for postoperative analgesia Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spread of sensorial block
The sensorial block will be evaluated with dermatomal examination
Measured: in postoperative sixth hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start15 Nov 2018
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onur Selvi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Onur Selvi, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744520
- Sponsor's protocol ID
- Sensorial Block assessment
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2018
- Last updated
- 4 Oct 2019
- 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study
- ClinicalTrials.gov ID
- NCT03744520
- Acronym / sponsor ID
- Sensorial Block assessment
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Onur SelviUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 16 Nov 2018 (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.
Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Experimental | Procedure: Erector spinae plane blockThe patients who had paravertebral interfacial plane block for postoperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who received successful erector spinae plane block for postoperative analgesia
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients who are not able to communicate with
- Patients who are on medication which may change the perception of pain.
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 |
|---|---|---|
| Erector spinae plane blockLocal anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process. | Procedure or surgery | ESP block group |
Primary outcome
Spread of sensorial block
Time frame: in postoperative sixth hours
The sensorial block will be evaluated with dermatomal examination
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 4 Oct 2019.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Erector spinae plane block in people with Regional Anesthesia Morbidity, run by Onur Selvi 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 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: finished, as of the sponsor's last update on 4 Oct 2019. 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?
Spread of sensorial block (time frame: in postoperative sixth 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 4 Oct 2019.