Sternotomy PainESPNCT04989933
Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery
A study testing Ultrasound-guided erector spinae plane block in people with Sternotomy Pain, run by Ataturk University.
Trial summary
The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sternotomy Pain
- What is being tested?
- Ultrasound-guided erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2021to 1 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery
Who cannot join
- chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study
The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.
This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.
- Conditions
- Sternotomy Pain
- 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
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| ESP 20 ml | Active comparator | Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine Receives: Procedure: Ultrasound-guided erector spinae plane block |
| ESP 30 ml | Active comparator | Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine 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.
Rescue analgesia
Total amount of rescue analgesic
Measured: Post-extubation 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start2 Aug 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternotomy PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989933
- Sponsor's protocol ID
- AtaturkU-AnkaraCH
- Other IDs
- Asli Demir, Ali Ahiskalioglu
- Acronym
- ESP
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04989933
- Acronym / sponsor ID
- ESP / AtaturkU-AnkaraCH
- Conditions
- Sternotomy Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 4 Aug 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.
The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.
This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP 20 ml | Active comparator | Procedure: Ultrasound-guided erector spinae plane blockUltrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine |
| ESP 30 ml | Active comparator | Procedure: Ultrasound-guided erector spinae plane blockUltrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery
Key exclusion criteria (1 listed)
- chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
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 blockUltrasound-Guided erector spinae plane block with 0.25% bupivacaine | Procedure or surgery | ESP 20 ml, ESP 30 ml |
Primary outcome
Rescue analgesia
Time frame: Post-extubation 24 hours
Total amount of rescue analgesic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided erector spinae plane block in people with Sternotomy Pain, run by Ataturk University.
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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Rescue analgesia (time frame: Post-extubation 24 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 Aug 2021.