The Analgesic Effect of Butorphanol After Cesarean Section

July 25, 2020 updated by: Deng Dongrui, Tongji Hospital
We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the vital signs of patients, general condition of newborns and pain assessment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: Observed group
Drug: butorphanol
Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from Visual Analogue Score for pain
Time Frame: 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
assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rates
Time Frame: at 24 hours, 30 hours, 36 hours after the cesarean section
heart rates（bpm)
at 24 hours, 30 hours, 36 hours after the cesarean section
jaundice index of the newborn,1 minute and 5 minutes Apgar score
Time Frame: 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.
jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section
blood pressure
Time Frame: at 24 hours, 30 hours, 36 hours after the cesarean section
blood pressure(mmHg)
at 24 hours, 30 hours, 36 hours after the cesarean section
breath
Time Frame: at 24 hours, 30 hours, 36 hours after the cesarean section
breath(bpm)
at 24 hours, 30 hours, 36 hours after the cesarean section
pulse
Time Frame: at 24 hours, 30 hours, 36 hours after the cesarean section
pulse(bpm)
at 24 hours, 30 hours, 36 hours after the cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: Xun Gong, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2020

Primary Completion (ANTICIPATED)

November 30, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

July 25, 2020

First Posted (ACTUAL)

July 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-C20200119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Analgesia

Clinical Trials on butorphanol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe