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Trial · NCT07901348

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryTotal opioid consumption in the first 24 hours0 to 24 hours after PCA connectionTotal opioid consumption, measured as the cumulative intravenous tramadol dose (mg) recorded by the patient-controlled analgesia device from PCA connection (hour 0) to 24 hours.
SecondaryPain at rest2, 4, 8, 12 and 24 hours after PCA connectionPain at rest on a 10-cm visual analog scale (0 = no pain, 10 = worst imaginable pain).
SecondaryPain during active knee flexion2, 4, 8, 12 and 24 hours after PCA connectionPain during active knee flexion on a 10-cm visual analog scale (0 = no pain, 10 = worst imaginable pain), measured after the spinal motor block has resolved (Bromage score 1).
SecondaryTime to first analgesic requestUp to 24 hours after PCA connectionTime (hours) from PCA connection to the first bolus request on the patient-controlled analgesia device.
SecondaryRescue analgesic requirement0 to 24 hours after PCA connectionProportion of patients who receive rescue intravenous dexketoprofen (given when the VAS score at rest is 4 or higher) and the number of rescue doses.
SecondaryTimed Up and Go test24, 48 and 72 hours after PCA connection
Time (seconds) to rise from a standard armchair, walk 3 meters, turn, walk back and sit down, performed with a walker under physiotherapist supervision. The proportion of patients unable to complete the test is also reported.
SecondaryStair climbing performancePostoperative day 2Number of steps climbed in a single attempt without stopping on a standard staircase (step height about 17 cm, one handrail), under physiotherapist supervision.
SecondaryQuality of recovery24 hours after PCA connectionTotal score of the Turkish version of the Quality of Recovery-15 questionnaire (range 0-150; higher scores indicate better recovery).
OtherLate pain scores36, 48, 60 and 72 hours after PCA connectionPain at rest and during active knee flexion on a 10-cm visual analog scale (0 = no pain, 10 = worst imaginable pain).
OtherLate opioid consumption24 to 48 hours and 48 to 72 hours after PCA connectionIntravenous tramadol consumption (mg) recorded by the patient-controlled analgesia device.
OtherOpioid-related side effects24, 48 and 72 hours after PCA connectionOpioid-Related Symptom Distress Scale: presence, frequency, severity and distress of 12 symptoms during the previous 24 hours.

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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