Trial · NCT04741880
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to T12 regression of the sensory block | Period: Day 0 postoperative | Time between the injection of bupivacaine into the subarachnoid space and the regression of sensory block to T12 dermatome (in minutes) |
| Secondary | Time to motor block regression | Day 0 postoperative | Time between the injection of bupivacaine into the subarachnoid space and the regression of motor block to the modified Bromage scale 1 (in minutes) |
| Secondary | Most rostral dermatome achieved by the sensory block | Day 0 postoperative | Evaluated as ordinal variable (see statistical analysis) |
| Secondary | Time to two-segment regression of the sensory block | Day 0 postoperative | Time between the injection of bupivacaine into the subarachnoid space and the regression of 2 dermatomes sensory block level (in minutes) |
| Secondary | Propofol dose at the operating room | Intraoperative | In mg |
| Secondary | Time to the first opioid rescue | Intraoperative | In mg |
| Secondary | Postoperative pain score at rest | Admission to the PACU, 2 postoperative hours, 24 postoperative hours, and worse in the first 24 postoperative hours measurements | Verbal numerical scale between 0 and 10, being 0 = "no pain" and 10 = "worst pain imaginable" |
| Secondary | Pain score at movement | 24 postoperative hours | Verbal numerical scale between 0 and 10, being 0 = "no pain" and 10 = "worst pain imaginable" |
| Secondary | Quality of recovery in 24 hours | 24 postoperative hours | Quality of recovery measured by the "40-item quality-of-recovery questionnaire" (QoR-40) |
| Secondary | Need for opioid analgesics (binary) | Between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours | YES/NO |
| Secondary | Need for opioid analgesics (continuous) | between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours | In oral morphine equivalents (in mg) |
| Secondary | Nausea or vomiting | Between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours | Presence of nausea or vomiting reported by the patient - YES/NO |
| Secondary | Dizziness | From intraoperative to 24 postoperative hours | Report of dizziness by patient - YES/NO |
| Secondary | Bradycardia | At the operating room (OR) and admission to the PACU up to 24 postoperative hours | Heart rate below 50 beats per minute (YES/NO) |
| Secondary | Other arrhythmias | At the OR and admission to the PACU up to 24 postoperative hours | Heart rhythm change except sinus bradycardia and sinus tachycardia (YES/NO) |
| Secondary | Hypotension | At the OR, between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours | MAP \< 65mmHg or presence of compatible symptoms (such as nausea, vomiting or cognitive impairments) |
| Secondary | Urinary retention | Between 0 and 24 postoperative hours | Voiding difficulty that requires bladder catheterization for relief by the assistant team |
| Secondary | Length of stay | Through study completion, an average of 30 days | Time between the end of the operation and administrative discharge in days |
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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GET https://conductscience.org/api/trials/v1/NCT04741880/registered