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Trial · NCT07900269

Registered outcomes14

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

ListOutcomeTime frameDescription
Primaryincidence of moderate to severe visceral pain within 24 hours postoperativelyat 6 hours, 12 hours, and 24 hours after surgery
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).The NRS scores for visceral pain at rest and during activity were assessed in parturients at 6 h , 12 h , and 24 h postoperatively. Moderate-to-severe visceral pain was defined as an NRS score of ≥4 (on a 0-10 scale) at any of these time points.
SecondaryFrequency of rescue analgesic use within 24 hours postoperativelywithin 24 hours after cesarean section
SecondaryThe area under the curve (AUC) of NRS scores for visceral pain at rest and during activity within 24 hours postoperatively in parturients.at 6 hours, 12 hours, and 24 hours after surgeryNumerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity)
SecondaryPre- and post-intervention 6-item STAI-S anxiety scoresPre-anesthesia , before operating room exit,at 6 hours、12 hours、and 24 hours after surgerySix-item Short-Form State-Trait Anxiety Inventory (STAI-S6): the raw sum score ranges from 6 to 24.Higher scores indicate a worse outcome (greater state anxiety).
SecondaryNRS scores for visceral pain at rest and during activity within 24 hours postoperatively (at 6 h, 12 h, and 24 h after surgery)at 6 hours, 12 hours, and 24 hours after surgeryNumerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
SecondaryHydromorphone equivalent dose within 24 hours after surgerywithin 24 hours after cesarean section
SecondaryEffective PCIA pump presses within 24 h postop.within 24 hours after cesarean sectionThe number of effective presses on the PCIA pump can be automatically counted by the pump's backend program.
Secondaryscore of pain sensitivity measurementbefore intervention in the pre-anesthesia room, immediately upon completion of surgery, and 24 hours postoperatively.
For the pressure algometer used to measure pain sensitivity, the relevant metric is the Pressure Pain Threshold (PPT). There is no universal minimum or maximum: values are device- and probe-dependent (theoretical minimum 0; e.g., 0-2000 kPa for a 1 cm² probe or 0-4000 kPa for a 0.5 cm² probe). Higher PPT scores indicate a better outcome (lower pressure pain sensitivity), whereas lower scores indicate greater pain sensitivity.
SecondaryNRS scores for incisional pain at rest and on movement within 24 hours after surgery.at 6 hours, 12 hours, and 24 hours after surgeryNumerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
SecondaryPostoperative adverse reactionswithin 24 hours after cesarean section
SecondaryAUC of incisional pain NRS scores at rest and on movement within 24 hours after surgery.at 6 hours, 12 hours, and 24 hours after surgeryNumerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
SecondaryChanges in maternal heart rate during cesarean section.during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closurematernal heart rate (beats/min) wil be measured solely by the operating room monitor
SecondaryChanges in maternal non-invasive blood pressure during cesarean section.during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closurenon-invasive blood pressure (systolic/diastolic, mmHg) wil be measured solely by the operating room monitor
SecondaryChanges in maternal pulse oxygen saturation during surgery.during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closureperipheral oxygen saturation (SpO₂, %) wil be measured solely by the operating room monitor

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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