Pain, PostoperativeNCT03739086
Retrospective Evaluation of Erector Spinae Plane Blocks
An observational study of Pain, Postoperative, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Retrospective Evaluation of Erector Spinae Plane Blocks Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- erector spinae plane block
- Type of treatment
- Surgery or procedure
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 14 Nov 2018
- 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 100 years
- All sexes
- Child, Adult, Older adult
Study population: all of the patients performed erector spinae plaen block
Who may be able to join
- patient performed erector spinae plane block
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University faculty of medicine
Istanbul, 34090
About this study
Official title: Evaluation of Erector Spinae Plane Block; Indications, Complications and Analgesic Effects
Retrospective Evaluation of Erector Spinae Plane Blocks
Read the detailed description
in our institue; we use erector spinae plane block as a part of multimodal analjesia. we want to evaluate block failures and complications related erector spinae plane block. In all patients performed regional anesthesia techniques, we use a regional anesthesia follow chart.
- Conditions
- Pain, Postoperative
- Being tested
- erector spinae plane block
- Medical subject headings
- Pain, Postoperative
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
unilateral or bilateral or bilevel erector spinae plane block performance for postoperative pain or acute pain
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
Measured: 14 months
Secondary outcomes (1)
block failure rate
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Jul 2017
- Primary completion1 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asst. Prof. Serkan Tulgar, M.D., Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739086
- Sponsor's protocol ID
- ESPB-retro
- Status last verified
- Nov 2018
- First submitted
- 21 Oct 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Erector Spinae Plane Block; Indications, Complications and Analgesic Effects
- ClinicalTrials.gov ID
- NCT03739086
- Acronym / sponsor ID
- ESPB-retro
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 13 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.
Retrospective Evaluation of Erector Spinae Plane Blocks
Detailed description
in our institue; we use erector spinae plane block as a part of multimodal analjesia. we want to evaluate block failures and complications related erector spinae plane block. In all patients performed regional anesthesia techniques, we use a regional anesthesia follow chart.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all of the patients performed erector spinae plaen block
Key inclusion criteria (1 listed)
- patient performed erector spinae plane block
Key exclusion criteria (1 listed)
- -
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 blockunilateral or bilateral or bilevel erector spinae plane block performance for postoperative pain or acute pain | Procedure or surgery | – |
Primary outcome
complication rate
Time frame: 14 months
1 secondary outcome
block failure rate
Time frame: 14 months
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 15 Nov 2018.
- Results publication: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Results publication: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- 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. 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 Pain, Postoperative, run by Maltepe University 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 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: finished, as of the sponsor's last update on 15 Nov 2018. 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?
complication rate (time frame: 14 months). 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 NCT03739086, which also lists 2 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 15 Nov 2018.