Trial · NCT07560722
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | NRS pruritus score at 24 hours after surgery | 24 hours after the surgery | The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching. |
| Secondary | 5-D itch scale at 72 hours after surgery | 72 hours after surgery | The duration, severity, outcome trend, life impairment, and pruritus site (5-D) were used to evaluate the patient's pruritus. Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching. |
| Secondary | NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery | 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery | The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching. |
| Secondary | The incidence of pruritus on the 24 hours after surgery | 24 hours after surgery | The NRS pruritus score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator. |
| Secondary | Total bile acid at 24 hours after surgery | 24 hours after surgery | The patient's fasting total bile acid level was checked the day before the operation. The investigators rechecked the fasting total bile acid levels 24 hours after the patient's surgery to assess the changes in total bile acid. |
| Secondary | Pain Score (NRS) | 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery | The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain. |
| Secondary | The incidence of postoperative sleep disturbance on the first、second and third postoperative nights | the first、second and third nights after surgery | The patient completed the Sleep Quality Scale (AIS，Athens Insomnia Scale) one day before the surgery. There are a total of 8 items in the AIS, with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AIS scores as statistical indicators. |
| Secondary | Postoperative anxiety | 72 hours after the surgery | The patient completed the Self-Rating Anxiety Scale (SAS, Self-Rating Anxiety Scale) one day before the surgery. The SAS consists of 20 items. Among them, 15 items are positive ratings (such as "I feel more nervous and anxious than usual"), and 5 items are negative ratings (such as "I feel everything is fine", which are the reverse items numbered 5, 9, 13, 17, and 19). The content covers subjective feelings of anxiety and various physical symptoms. The investigators asked the patient to fill out this questionnaire again 72 hours after the surgery to assess the changes in anxiety. |
| Secondary | Postoperative depression | 72 hours after the surgery | The patient completed the Edinburgh Depression Scale (EPDS) one day before the surgery. The EPDS consists of 10 items, covering aspects such as mood, anxiety, and self-blame. Scores range from 0 to 9: within the normal range, no special intervention is required; 10-12: borderline range, suggesting a need for follow-up observation; 13-30: screening positive, indicating possible postpartum depression, and further assessment is necessary. The investigators asked the patient to fill out this questionnaire again at the seventy-second hour after the surgery to assess the changes in depression. |
| Secondary | Key time points of the surgery | Perioperative period | 1. Duration of anesthesia （minutes） 2. Duration of surgery （minutes） 3. The time of fetal delivery（minutes） |
| Secondary | Intraoperative average blood pressure（mmHg） | Perioperative period | |
| Secondary | Intraoperative average heart rate（times per minute） | Perioperative period | |
| Secondary | Intraoperative average blood oxygen saturation（%） | Perioperative period | |
| Secondary | Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.) | Perioperative period | |
| Secondary | Adverse event | Within 72 hours after the surgery | All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded. |
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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