Postoperative Nausea and Vomiting (PONV)NCT07804732
Early Postoperative Pain After Cardiac Surgery
An observational study of Postoperative Nausea and Vomiting (PONV), run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study will evaluate factors that may be associated with pain during the first 24 hours after open heart surgery. The study will include adult patients who underwent coronary artery bypass grafting (CABG), heart valve surgery, or combined cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2026to 7 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients who underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery, at a tertiary care center between April 1, 2025 and April 1, 2026. Eligible patients will be identified retrospectively from existing electronic medical records according to the predefined inclusion and exclusion criteria.
Who may be able to join
- Age ≥18 years
- Underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery
- Complete perioperative and postoperative pain data available in the medical records
Who cannot join
- Incomplete medical records
- Reoperation within the first 24 postoperative hours
- Chronic opioid use
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Antalya Training and Research Hospital
Antalya, 07100
About this study
Official title: Early Postoperative Pain and Related Outcomes After Cardiac Surgery: A Retrospective Cohort Study
This observational study will evaluate factors that may be associated with pain during the first 24 hours after open heart surgery. The study will include adult patients who underwent coronary artery bypass grafting (CABG), heart valve surgery, or combined cardiac surgery.
Researchers will retrospectively review existing medical records to examine whether patient characteristics, preoperative anxiety and depression, and factors related to surgery and anesthesia are associated with postoperative pain. The study will also evaluate postoperative nausea and vomiting and the need for additional pain medication.
No treatment or intervention will be assigned to participants as part of this study. Study data will be collected retrospectively from existing medical records.
Read the detailed description
Postoperative pain after cardiac surgery is influenced by multiple patient-related, psychological, surgical, and perioperative factors. The relative contribution of these factors to early postoperative pain and related outcomes remains uncertain.
This retrospective observational cohort study will evaluate factors associated with early postoperative pain in adult patients who underwent open cardiac surgery, including coronary artery bypass grafting, valve surgery, or combined cardiac procedures. Existing medical records will be retrospectively reviewed.
The analysis will examine demographic characteristics, preoperative anxiety and depression, surgical characteristics, and perioperative factors in relation to early postoperative pain. Preoperative anxiety and depression will be evaluated using available Hospital Anxiety and Depression Scale (HADS) scores. Postoperative pain will be assessed using Numeric Rating Scale (NRS) measurements recorded during the first 24 hours after surgery. Postoperative nausea and vomiting and the requirement for additional rescue analgesia will also be evaluated as related postoperative outcomes.
Associations between these clinical and psychological factors and postoperative outcomes will be examined using appropriate statistical analyses. No study-specific treatment or intervention will be assigned to participants, as all study data will be obtained retrospectively from existing medical records.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- Cardiac Surgery, Postoperative Pain, Preoperative Anxiety, Preoperative Depression, Multimodal Analgesia, Postoperative Nausea and Vomiting, Rescue Analgesia, Numeric Rating Scale
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Cohort | Adult patients who underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery, between April 1, 2025 and April 1, 2026. Existing medical records will be retrospectively reviewed to evaluate early postoperative pain and related outcomes. No study-specific treatment or intervention will be assigned by the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative Pain Score During the First 24 Hours
Postoperative pain will be assessed at rest using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain. NRS scores recorded at 0, 3, 6, 12, and 24 hours after the initial postoperative assessment in the intensive care unit will be used to calculate the mean pain score (NRSmean) for the first 24 postoperative hours.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start10 Aug 2026
- Primary completion5 Sep 2026
- Study completion7 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies 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
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804732
- Sponsor's protocol ID
- 2026-242
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because the study is based on a retrospective review of clinical medical records and no IPD-sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Pain and Related Outcomes After Cardiac Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07804732
- Acronym / sponsor ID
- 2026-242
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- Cardiac Surgery, Postoperative Pain, Preoperative Anxiety, Preoperative Depression, Multimodal Analgesia, Postoperative Nausea and Vomiting, Rescue Analgesia, Numeric Rating Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 5 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 4 Sep 2026 (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.
This observational study will evaluate factors that may be associated with pain during the first 24 hours after open heart surgery. The study will include adult patients who underwent coronary artery bypass grafting (CABG), heart valve surgery, or combined cardiac surgery.
Researchers will retrospectively review existing medical records to examine whether patient characteristics, preoperative anxiety and depression, and factors related to surgery and anesthesia are associated with postoperative pain. The study will also evaluate postoperative nausea and vomiting and the need for additional pain medication.
No treatment or intervention will be assigned to participants as part of this study. Study data will be collected retrospectively from existing medical records.
Detailed description
Postoperative pain after cardiac surgery is influenced by multiple patient-related, psychological, surgical, and perioperative factors. The relative contribution of these factors to early postoperative pain and related outcomes remains uncertain.
This retrospective observational cohort study will evaluate factors associated with early postoperative pain in adult patients who underwent open cardiac surgery, including coronary artery bypass grafting, valve surgery, or combined cardiac procedures. Existing medical records will be retrospectively reviewed.
The analysis will examine demographic characteristics, preoperative anxiety and depression, surgical characteristics, and perioperative factors in relation to early postoperative pain. Preoperative anxiety and depression will be evaluated using available Hospital Anxiety and Depression Scale (HADS) scores. Postoperative pain will be assessed using Numeric Rating Scale (NRS) measurements recorded during the first 24 hours after surgery. Postoperative nausea and vomiting and the requirement for additional rescue analgesia will also be evaluated as related postoperative outcomes.
Associations between these clinical and psychological factors and postoperative outcomes will be examined using appropriate statistical analyses. No study-specific treatment or intervention will be assigned to participants, as all study data will be obtained retrospectively from existing medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Cohort | – | –Adult patients who underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery, between April 1, 2025 and April 1, 2026. Existing medical records will be retrospectively reviewed to evaluate early postoperative pain and related outcomes. No study-specific treatment or intervention will be assigned by the investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients who underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery, at a tertiary care center between April 1, 2025 and April 1, 2026. Eligible patients will be identified retrospectively from existing electronic medical records according to the predefined inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Underwent open cardiac surgery, including coronary artery bypass grafting (CABG), valve surgery, or combined cardiac surgery
- Complete perioperative and postoperative pain data available in the medical records
Key exclusion criteria (4 listed)
- Incomplete medical records
- Reoperation within the first 24 postoperative hours
- Chronic opioid use
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Postoperative Pain Score During the First 24 Hours
Time frame: First 24 hours after surgery
Postoperative pain will be assessed at rest using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain. NRS scores recorded at 0, 3, 6, 12, and 24 hours after the initial postoperative assessment in the intensive care unit will be used to calculate the mean pain score (NRSmean) for the first 24 postoperative hours.
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because the study is based on a retrospective review of clinical medical records and no IPD-sharing plan was established for this study.
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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 Nausea and Vomiting (PONV), 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 4 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 1 Oct 2026. 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?
Mean Postoperative Pain Score During the First 24 Hours (time frame: First 24 hours after surgery). 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 1 Oct 2026.