Trial · NCT07882836
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Clinically Significant Chronic Poststernotomy Pain | Postoperative Day 90 | The proportion of participants with clinically significant chronic poststernotomy pain on postoperative day 90 will be assessed. Clinically significant chronic poststernotomy pain will be defined as pain that develops after surgery or is aggravated by surgery; is localized to the sternotomy line, parasternal region, chest tube insertion sites, or thoracic wall area related to internal thoracic artery dissection; persists or recurs at 3 months after surgery; and has an average intensity of at least 3 on the 0-10 Numeric Rating Scale (NRS) during the preceding 7 days. Pain better explained by sternal wound infection, mediastinitis, sternal instability or nonunion, recurrent myocardial ischemia, malignancy, or another clinical condition will not be classified as chronic poststernotomy pain. The outcome will be assessed by an outcome assessor blinded to treatment allocation. Higher incidence indicates a less favorable outcome. |
| Secondary | Postoperative Pain Intensity at Rest | 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5 | Pain intensity at rest will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Secondary | Postoperative Pain Intensity During Coughing or Deep Breathing | 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5 | Pain intensity during coughing or deep breathing will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Secondary | Postoperative Pain Intensity During Mobilization | 6, 12, 24, 48, and 72 hours after surgery and postoperative day 5, or at hospital discharge if discharge occurs before postoperative day 5 | Pain intensity during mobilization will be assessed using the 0-10 Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Mobilization pain will be assessed only when mobilization is clinically feasible. |
| Secondary | Intraoperative Opioid Consumption | Intraoperative period | Total opioid consumption administered during surgery will be recorded and converted to morphine milligram equivalents (MME). Higher values indicate greater opioid consumption. |
| Secondary | Requirement for Rescue Analgesia | From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first | The proportion of participants requiring at least one rescue analgesic intervention will be recorded. The protocol-defined primary criterion for rescue analgesia is a score of 4 or higher on the 0-10 Numeric Rating Scale (NRS) at rest or during coughing or movement; rescue analgesia may also be administered according to clinical need irrespective of the NRS threshold. |
| Secondary | Number of Rescue Analgesic Administrations | From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first | The total number of rescue analgesic administrations received by each participant during the assessment period will be recorded. Higher values indicate greater rescue analgesic requirements. |
| Secondary | Time to First Rescue Analgesia | From the end of surgery through postoperative day 5 or hospital discharge, whichever occurs first | Time from the end of surgery to the first administration of rescue analgesia will be recorded in hours. Participants who do not require rescue analgesia during the observation period will be recorded as having no rescue analgesic event during that period. |
| Secondary | Incidence of Postoperative Nausea | From the end of surgery through 120 hours after surgery or hospital discharge, whichever occurs first | The proportion of participants experiencing at least one episode of postoperative nausea during the assessment period will be recorded. |
| Secondary | Incidence of Postoperative Oversedation | From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first | The proportion of participants experiencing at least one episode of clinically significant oversedation during the assessment period will be recorded. Oversedation will be defined as inability to be easily awakened, requirement for repeated stimulation, or sedation sufficiently severe to cause clinically significant impairment of communication. |
| Secondary | Incidence of Respiratory Depression | From the end of surgery through 5 days after surgery or hospital discharge, whichever occurs first | The proportion of participants experiencing at least one episode of respiratory depression during the assessment period will be recorded. Respiratory depression will be defined as a respiratory rate below 8 breaths per minute, clinically significant inadequate ventilation, or opioid-associated impairment of oxygenation. |
| Secondary | Time to Tracheal Extubation | Up to postoperative day 90 | Time from the end of surgery to first tracheal extubation will be recorded in hours. Participants who do not undergo tracheal extubation during the observation period will be recorded as not having achieved the extubation event. Extubation decisions will be made by the responsible clinical team according to routine institutional criteria and will not be accelerated or delayed for study purposes. |
| Secondary | Duration of Invasive Mechanical Ventilation | Up to postoperative day 90 | Total duration of postoperative invasive mechanical ventilation will be recorded in hours, from the end of surgery until final liberation from invasive mechanical ventilation. Higher values indicate a longer duration of invasive mechanical ventilation. |
| Secondary | Intensive Care Unit Length of Stay | Up to postoperative day 90 | Length of stay in the intensive care unit (ICU) will be recorded in days, from admission to the ICU after surgery until final discharge from the ICU. Higher values indicate a longer ICU stay. |
| Secondary | Hospital Length of Stay | Up to postoperative day 90 | Total hospital length of stay will be recorded in days, from the date of admission for surgery until final discharge from the index hospitalization. Higher values indicate a longer hospital stay. |
| Secondary | Incidence of Persistent Postoperative Pain | Postoperative Day 30 | The proportion of participants reporting persistent surgery-related pain involving the sternotomy or associated thoracic surgical areas on postoperative day 30 will be recorded. |
| Secondary | Presence of Any Chronic Poststernotomy Pain | Postoperative Day 90 | The proportion of participants reporting pain that persists or recurs at 3 months after surgery and is considered related to the sternotomy or associated thoracic surgical areas will be recorded, regardless of pain intensity. |
| Secondary | Average Chronic Poststernotomy Pain Intensity | Postoperative Day 90 | Among participants reporting chronic poststernotomy pain, a single recalled rating of average pain intensity during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Secondary | Worst Chronic Poststernotomy Pain Intensity | Postoperative Day 90 | Among participants reporting chronic poststernotomy pain, a single recalled rating of the worst pain intensity experienced during the preceding 7 days will be obtained on postoperative day 90 using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Secondary | Neuropathic Pain Features Assessed With the Douleur Neuropathique en 4 Questions (DN4) | Postoperative Day 90 | Among participants reporting pain at postoperative day 90, neuropathic pain features will be assessed using the Douleur Neuropathique en 4 Questions (DN4). The DN4 consists of 10 dichotomously scored items, with a total score ranging from 0 to 10. Higher scores indicate a greater likelihood that the pain has a neuropathic component. A score of 4 or higher will be considered indicative of neuropathic pain characteristics. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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