The Analgesic Effect of Butorphanol After Cesarean Section
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the vital signs of patients, general condition of newborns and pain assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 29, 2020
June 1, 2020
4 months
February 3, 2020
July 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change from Visual Analogue Score for pain
VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants
assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section
Secondary Outcomes (5)
heart rates
at 24 hours, 30 hours, 36 hours after the cesarean section
jaundice index of the newborn,1 minute and 5 minutes Apgar score
jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section
blood pressure
at 24 hours, 30 hours, 36 hours after the cesarean section
breath
at 24 hours, 30 hours, 36 hours after the cesarean section
pulse
at 24 hours, 30 hours, 36 hours after the cesarean section
Study Arms (2)
Observed group
EXPERIMENTALControl group
NO INTERVENTIONInterventions
Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section
Eligibility Criteria
You may qualify if:
- Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were eligible to participate. undergoing ；No drug sensitive history
You may not qualify if:
- Patients with a history of anesthetics allergy and patients with preterm labor, multiple pregnancies and severe obstetric complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xun Gong
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor,chief doctor
Study Record Dates
First Submitted
February 3, 2020
First Posted
July 29, 2020
Study Start
August 1, 2020
Primary Completion
November 30, 2020
Study Completion
December 31, 2020
Last Updated
July 29, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share