Regional AnesthesiaNCT04706780
Hemi-diaphragmatic Paresis After Erector Spinae Plane Block
An observational study of Regional Anesthesia and Carotid Endarterectomy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Regional Anesthesia, Carotid Endarterectomy
- What is being tested?
- ESP block
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 7 Jul 2021
- How long will I take part?
- 4 Months
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: carotid endarterectomy
Who may be able to join
- 18 - 85 years
- American Society of Anesthesiology (ASA) I-III
- elective carotid endarterectomy
Who cannot join
- patient's refusal
- under 18 years of age or over 65 years of age
- ASA IV and above
- known allergy to local anaesthetic drugs
- the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
- history of neurological and/or neuromucular disease
Show all 9Show fewer
- history of severe bronchopulmonary disease
- a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Hemi-diaphragmatic Paresis After Ultrasound-guided Erector Spinae Plane Block in Carotid Endarterectomy
To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block
Read the detailed description
The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. The aim of the study is to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.
- Conditions
- Regional Anesthesia, Carotid Endarterectomy
- Being tested
- ESP block
- Keywords
- Regional anesthesia, Erector spinae plane block, Carotid endarterectomy, Ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockOther
ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. Receives: Other: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hemi-diaphragmatic paresis
Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
Measured: 30 minutes
Secondary outcomes (4)
opioid consumption
intraoperative opioid consumption will be recorded
Measured: 1 hour
postoperative analgesia consumption
postoperative analgesia consumption for 24 hours will be recorded
Measured: 24 hours
intraoperative local anesthetic consumption
amount of intraoperative additional local anesthetic consumption will be recorded
Measured: 1 hour
Postoperative Numeric Rating Scale (NRS) score
postoperative pain assessment will be recorded using NRS score (NRS 0=no pain, NRS 10= most severe possible)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start20 Jan 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Why it stopped: insufficient number of patients
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 Regional 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, Principal investigator, Antalya TRHAli Sait Kavaklı, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706780
- Sponsor's protocol ID
- 19/27
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ueshima H, Hiroshi O. RETRACTED: Erector spinae plane block for carotid endarterectomy. J Clin Anesth. 2018 Aug;48:11. doi: 10.1016/j.jclinane.2018.04.004. Epub 2018 Apr 21. No abstract available.
PubMed 29684726Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemi-diaphragmatic Paresis After Ultrasound-guided Erector Spinae Plane Block in Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT04706780
- Acronym / sponsor ID
- 19/27
- Conditions
- Regional Anesthesia, Carotid Endarterectomy
- Keywords
- Regional anesthesia, Erector spinae plane block, Carotid endarterectomy, Ultrasound guidance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient number of patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 13 Jan 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.
To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block
Detailed description
The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. The aim of the study is to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESP block group | – | Other: ESP blockDiaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- carotid endarterectomy
Key inclusion criteria (3 listed)
- 18 - 85 years
- American Society of Anesthesiology (ASA) I-III
- elective carotid endarterectomy
Key exclusion criteria (9 listed)
- patient's refusal
- under 18 years of age or over 65 years of age
- ASA IV and above
- known allergy to local anaesthetic drugs
- the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
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 |
|---|---|---|
| ESP blockESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. | Other | ESP block group |
Primary outcome
incidence of hemi-diaphragmatic paresis
Time frame: 30 minutes
Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
4 secondary outcomes
opioid consumption
Time frame: 1 hour
postoperative analgesia consumption
Time frame: 24 hours
intraoperative local anesthetic consumption
Time frame: 1 hour
Postoperative Numeric Rating Scale (NRS) score
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: insufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 29684726Ueshima H, Hiroshi O. RETRACTED: Erector spinae plane block for carotid endarterectomy. J Clin Anesth. 2018 Aug;48:11. doi: 10.1016/j.jclinane.2018.04.004. Epub 2018 Apr 21. No abstract available.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- 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.
Arzu Karaveli principal investigator
Antalya TRH
Ali Sait Kavaklı principal investigator
Antalya TRH
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 and Carotid Endarterectomy, run by Antalya 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 9 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 30 Jul 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?
The study was stopped early (reason given: insufficient number of patients). 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?
incidence of hemi-diaphragmatic paresis (time frame: 30 minutes). 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 NCT04706780, 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 30 Jul 2021.