The Analgesic Effect of Butorphanol After Cesarean Section

Not Applicable

• Conditions: Analgesia
• Interventions: Drug: butorphanol

• Registration Number: NCT04490980
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-03
• Status Verified: 2020-06
• Study First Submitted QC: 2020-07-25
• Last Update Submitted: 2020-07-25
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29
• Study Start: 2020-08-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were eligible to participate. undergoing ；No drug sensitive history

Exclusion Criteria

Patients with a history of anesthetics allergy and patients with preterm labor, multiple pregnancies and severe obstetric complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observed group	butorphanol	-

Primary Outcome Measures

Name	Time	Method
change from Visual Analogue Score for pain	assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section	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

Secondary Outcome Measures

Name	Time	Method
jaundice index of the newborn,1 minute and 5 minutes Apgar score	jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section	Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.
blood pressure	at 24 hours, 30 hours, 36 hours after the cesarean section	blood pressure(mmHg)
pulse	at 24 hours, 30 hours, 36 hours after the cesarean section	pulse(bpm)
heart rates	at 24 hours, 30 hours, 36 hours after the cesarean section	heart rates（bpm)
breath	at 24 hours, 30 hours, 36 hours after the cesarean section	breath(bpm)