Postoperative PainNCT06558123
Deep Parasternal Intercostal Plane (DPIP) Block
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- block
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 20 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who will undergo sternotomy
Who may be able to join
- Adult patients aged 18 years and older
- American Society of Anesthesiologists physical status of II-III
- Undergoing elective coronary artery bypass grafting (CABG), valve repair/replacement, or combined CABG/valve procedure via median sternotomy
Who cannot join
- Patients who are unable to communicate
- Patients who have had emergency surgery, reoperation, thoracotomy or mastectomy
- Patients with a history of chronic pain
- Patients who are using chronic opioids or sedatives
- Patients who have had a re-sternotomy within 24 hours of surgery
- Patients with liver or kidney failure
- Patients who are using narcotics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Comparison of the Effects of Single-Level and Two-Level Deep Parasternal Intercostal Plane (DPIP) Block on Postoperative Sternotomy Pain in Cardiac Surgery
In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.
- Conditions
- Postoperative Pain
- Being tested
- 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.
blockProcedure or surgery
Single Level and Two Level Deep Parasternal Intercostal Plane (DPIP) Block
| Study group | Role | What they receive |
|---|---|---|
| Control | single level Receives: Procedure: block | |
| study | two level Receives: Procedure: block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale
24 hours pain
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Aug 2024
- Primary completion15 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558123
- Sponsor's protocol ID
- istinye university block
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Min J, Chen S. Sensory Assessment and Block Duration of Deep Parasternal Intercostal Plane Block in Patients Undergoing Cardiac Surgery: A Prospective Observational Study. Pain Ther. 2022 Sep;11(3):951-958. doi: 10.1007/s40122-022-00403-y. Epub 2022 Jun 25.
PubMed 35751781Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
PubMed 38148266Gelinas C. Management of pain in cardiac surgery ICU patients: have we improved over time? Intensive Crit Care Nurs. 2007 Oct;23(5):298-303. doi: 10.1016/j.iccn.2007.03.002. Epub 2007 Apr 19.
PubMed 17448662
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Single-Level and Two-Level Deep Parasternal Intercostal Plane (DPIP) Block on Postoperative Sternotomy Pain in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06558123
- Acronym / sponsor ID
- istinye university block
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 16 Aug 2024 (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.
In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: blocksingle level |
| study | – | Procedure: blocktwo level |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who will undergo sternotomy
Key inclusion criteria (3 listed)
- Adult patients aged 18 years and older
- American Society of Anesthesiologists physical status of II-III
- Undergoing elective coronary artery bypass grafting (CABG), valve repair/replacement, or combined CABG/valve procedure via median sternotomy
Key exclusion criteria (7 listed)
- Patients who are unable to communicate
- Patients who have had emergency surgery, reoperation, thoracotomy or mastectomy
- Patients with a history of chronic pain
- Patients who are using chronic opioids or sedatives
- Patients who have had a re-sternotomy within 24 hours of surgery
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 |
|---|---|---|
| blockSingle Level and Two Level Deep Parasternal Intercostal Plane (DPIP) Block | Procedure or surgery | Control, study |
Primary outcome
numeric rating scale
Time frame: 4 month
24 hours pain
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 27 Dec 2024.
- Background: PubMed 35751781Zhang Y, Min J, Chen S. Sensory Assessment and Block Duration of Deep Parasternal Intercostal Plane Block in Patients Undergoing Cardiac Surgery: A Prospective Observational Study. Pain Ther. 2022 Sep;11(3):951-958. doi: 10.1007/s40122-022-00403-y. Epub 2022 Jun 25.
- Results publication: PubMed 38148266Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
- Results publication: PubMed 17448662Gelinas C. Management of pain in cardiac surgery ICU patients: have we improved over time? Intensive Crit Care Nurs. 2007 Oct;23(5):298-303. doi: 10.1016/j.iccn.2007.03.002. Epub 2007 Apr 19.
- 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 Postoperative Pain, run by Istinye 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 3 inclusion and 7 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 27 Dec 2024. 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?
numeric rating scale (time frame: 4 month). 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 NCT06558123, which also lists 3 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 27 Dec 2024.