Post Operative AnalgesiaSPINENCT04449367
ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY
An observational study of Post Operative Analgesia, run by Dubai Health Authority at 1 site in United Arab Emirates.
Trial summary
the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- ultrasound guided erector spinae plane block
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 26 Aug 2018to 22 Jun 2020
- How long will I take part?
- 2 Days
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients underging thoracic spine sugery
Who may be able to join
- postoperative thoracic spine sugery
Who cannot join
- less then 18 years
- more than 65 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY
the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery
Read the detailed description
bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia \& its effectiveness would be evaluated for 2 days
- Conditions
- Post Operative Analgesia
- Being tested
- ultrasound guided erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided erector spinae plane blockProcedure or surgery
bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain
| Study group | Role | What they receive |
|---|---|---|
| Randomized and Single-Arm Trials | a sham comparator (no intervention) Receives: Procedure: ultrasound guided erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery
postoperative analgesia
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start26 Aug 2018
- Primary completion22 Apr 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Dubai Health Authority
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Manar Mamdouh Fahmy Elsharkawi, Dubai Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449367
- Sponsor's protocol ID
- DSREC-04/2018_01
- Acronym
- SPINE
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY
- ClinicalTrials.gov ID
- NCT04449367
- Acronym / sponsor ID
- SPINE / DSREC-04/2018_01
- Conditions
- Post Operative Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dubai Health AuthorityOther government
- Study start
- 26 Aug 2018 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 26 Jun 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 effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery
Detailed description
bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia \& its effectiveness would be evaluated for 2 days
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomized and Single-Arm Trials | – | Procedure: ultrasound guided erector spinae plane blocka sham comparator (no intervention) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients underging thoracic spine sugery
Key inclusion criteria (1 listed)
- postoperative thoracic spine sugery
Key exclusion criteria (2 listed)
- less then 18 years
- more than 65 years
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 |
|---|---|---|
| ultrasound guided erector spinae plane blockbilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain | Procedure or surgery | Randomized and Single-Arm Trials |
Primary outcome
ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery
Time frame: 2 days
postoperative analgesia
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 30 Jun 2020.
- 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?
An observational study of Post Operative Analgesia, run by Dubai Health Authority at 1 site in United Arab Emirates.
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 2 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 30 Jun 2020. 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 Arab Emirates. 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?
ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery (time frame: 2 days). 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 30 Jun 2020.