NCT02595333

Brief Summary

This study aims to compare the pain degree between primary cesarean section and repeated cesarean section, and investigate the role of flurbiprofen axetil in postoperative analgesia, so as to provide reference for clinical practice.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
unknown

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

October 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

October 26, 2015

Last Update Submit

November 2, 2015

Conditions

Keywords

repeat cesarean sectionpain

Outcome Measures

Primary Outcomes (1)

  • The scores of incision pain and uterine contraction pain 24 h, 48 h and 72 h after operation

    up to 24 months

Study Arms (4)

Group SF1

EXPERIMENTAL

primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

Drug: Group SF1

Group S1

EXPERIMENTAL

primary cesarean section+postoperative analgesia with sufentanil group

Drug: Group S1

Group SF2

EXPERIMENTAL

repeated cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

Drug: Group SF2

Group S2

EXPERIMENTAL

repeated cesarean section+postoperative analgesia with sufentanil group

Drug: Group S2

Interventions

primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

Also known as: 1
Group SF1

sufentanil was administered for analgesia in primary cesarean section

Also known as: 2
Group S1

sufentanil and flurbiprofen was administered for analgesia in repeated cesarean section

Also known as: 3
Group SF2

sufentanil was administered for analgesia in repeated cesarean section

Also known as: 4
Group S2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eighty women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

You may not qualify if:

  • Diabetes controlled by insulin
  • Preeclampsia
  • Heart diseases
  • History of taking drugs potentially affecting cardiovascular system.
  • Patients fasted for at least 8 hours before surgery and no premedication was given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shaoqiang Huang

    Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Shen Sun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and Gynecology Hospital

Study Record Dates

First Submitted

October 26, 2015

First Posted

November 3, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

November 3, 2015

Record last verified: 2015-10