NCT07804732

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

26 days

First QC Date

September 1, 2026

Last Update Submit

September 30, 2026

Conditions

Keywords

Cardiac SurgeryPostoperative PainPreoperative AnxietyPreoperative DepressionMultimodal AnalgesiaPostoperative Nausea and VomitingRescue AnalgesiaNumeric Rating Scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    First 24 hours after surgery

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete medical records
  • Reoperation within the first 24 postoperative hours
  • Chronic opioid use
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingPain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingPainNeurologic Manifestations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

August 10, 2026

Primary Completion

September 5, 2026

Study Completion

September 7, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations