CClinicalTrials.gg
Status unknownNCT04490980Updated Jul 29, 2020

The Analgesic Effect of Butorphanol After Cesarean Section

An interventional study of butorphanol in Analgesia, sponsored by Tongji Hospital. Status unknown. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-29.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Analgesia
03

In context

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Observed group

    Drug: butorphanol

  • No intervention
    Control group

Interventions

  • Drugbutorphanol

    Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section

06

What researchers measure

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

    Time frame: assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section

Secondary outcomes

  1. heart rates

    heart rates(bpm)

    Time frame: at 24 hours, 30 hours, 36 hours after the cesarean section

  2. jaundice index of the newborn,1 minute and 5 minutes Apgar score

    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.

    Time frame: jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section

  3. blood pressure

    blood pressure(mmHg)

    Time frame: at 24 hours, 30 hours, 36 hours after the cesarean section

  4. breath

    breath(bpm)

    Time frame: at 24 hours, 30 hours, 36 hours after the cesarean section

  5. pulse

    pulse(bpm)

    Time frame: at 24 hours, 30 hours, 36 hours after the cesarean section

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04490980
Lead sponsor
Tongji Hospital
Responsible party
Deng Dongrui (professor,chief doctor, Tongji Hospital) — Principal investigator
First posted
Jul 29, 2020
Start date
Aug 1, 2020 (estimated)
Primary completion
Nov 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 29, 2020

Study contacts

Xun Gong, Doctor
Contact
gongxun4019@163.com
13886174675
Xun Gong
study chair · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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