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Trial · NCT07878013

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCumulative Morphine Consumption Within 24 Hours After SurgeryFrom Hour 0 (awake in the recovery room) to Hour 24 after surgery
Total amount of intravenous morphine (mg) delivered by the patient-controlled analgesia (PCA) pump, including any supplemental morphine, from Hour 0 to Hour 24. Hour 0 is defined as the time the participant is awake in the recovery room and able to self-report pain and use the PCA device.
SecondaryCumulative Morphine Consumption Within 12 Hours After SurgeryFrom Hour 0 (awake in the recovery room) to Hour 12 after surgeryTotal amount of intravenous morphine (mg) delivered by the PCA pump, including any supplemental morphine, from Hour 0 to Hour 12.
SecondaryPain Score at RestHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgeryPain intensity at rest measured on a 0-10 Visual Analogue Scale (0 = no pain, 10 = worst imaginable pain). One score is recorded at each time point.
SecondaryPain Score on MovementHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgery
Pain intensity on movement measured on a 0-10 Visual Analogue Scale (0 = no pain, 10 = worst imaginable pain). At each time point, the participant is asked to cough and flex the knees, then rates the worst pain experienced during these movements as a single score.
SecondaryTotal Intraoperative Fentanyl ConsumptionFrom induction of anesthesia to the end of surgery
Total fentanyl dose (µg) from induction of anesthesia to the end of surgery, including the induction dose and supplemental doses given when the PRST score (blood pressure, heart rate, sweating, tearing) is 4 or higher.
SecondaryIntraoperative Heart RateBefore induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closure.Heart rate (beats/min)
SecondaryIntraoperative Mean Arterial PressureBefore induction, before intubation, after intubation, before skin incision, 5, 15, 30 and 60 minutes after skin incision, before skin closure, and 5 minutes after skin closureMean arterial pressure (mmHg)
SecondaryPostoperative Heart RateHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgeryHeart rate (beats/min)
SecondaryPostoperative Mean Arterial PressureHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgeryMean arterial pressure (mmHg)
SecondaryPostoperative Respiratory RateHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgeryRespiratory rate (breaths/min)
SecondaryPostoperative Peripheral Oxygen SaturationHour 0 (awake in the recovery room), and Hours 1, 2, 4, 8, 12 and 24 after surgeryPeripheral oxygen saturation (%) measured by pulse oximetry
SecondaryTime to First Analgesic RequestFrom Hour 0 (awake in the recovery room) up to Hour 24 after surgeryTime (minutes) from Hour 0 to the participant's first PCA demand. Participants are instructed to press the PCA button when pain is 4 or higher on the Visual Analogue Scale.

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.

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