NCT02537665

Brief Summary

To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

August 27, 2015

Last Update Submit

August 31, 2015

Conditions

Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

  • the incidence of injury to blood vessel during epidural catheter placement

    5 minutes

Study Arms (2)

incidence of bleeding

OTHER

the effect of the epidural catheter filled with heated or normal saline before inserting into epidural on the incidence of bleeding.

Other: heating precondition

inserting time of catheter

PLACEBO COMPARATOR

record the time from beginning of catheter inserting to completing the placement of the catheter.

Other: heating precondition

Interventions

heating preconditionOTHER
incidence of bleedinginserting time of catheter

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective cesarean delivery
  • Epidural anesthesia.

You may not qualify if:

  • blood coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

Central Study Contacts

Guiqi Geng, PhD

CONTACT

86 21 33189900mzgengguiqi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 1, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

CN(1)