NCT03740399

Brief Summary

The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

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

April 19, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

October 19, 2018

Last Update Submit

November 10, 2018

Conditions

Regional Anesthesia Morbidity

Keywords

sitting positionlateral decubitus positionspinal block

Outcome Measures

Primary Outcomes (1)

  • spinal anesthesia success

    The free flow of clear cerebrospinal fluid (CSF) upon first attempt was considered to be evidence of a successful LP.

    spinal anesthesia success will be 15 minutes in intraoperative

Study Arms (3)

Group sitting

ACTIVE COMPARATOR

we are performing spinal anesthesia in sitting position pregnant patients

Procedure: spinal anesthesia

Group lateral decubitus position

ACTIVE COMPARATOR

we are performing spinal anesthesia in lateral decubitus position pregnant patients

Procedure: spinal anesthesia

Group Modified 45-degree head-up tilt

ACTIVE COMPARATOR

we are performing spinal anesthesia in Modified 45-degree head-up tilt position pregnant patients

Procedure: spinal anesthesia

Interventions

spinal anesthesiaPROCEDURE

Investigators will perform spinal anesthesia for section

Group Modified 45-degree head-up tiltGroup lateral decubitus positionGroup sitting

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant womans
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • caesarean section
  • years old
  • ASA I-II risk

You may not qualify if:

  • heart failure
  • patient's refusal
  • thrombocytopenia
  • coagulation disorder
  • heart valve diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Sevtap Hekimoglu Sahin, Proffesor

    Trakya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevtap Hekimoglu Sahin, Professor

CONTACT

+90-284-235-76-41sevtaphekimoglu@mynet.com

Beyhan Karamanlıoglu

CONTACT

beykar@mynet.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 19, 2018

First Posted

November 14, 2018

Study Start

April 19, 2018

Primary Completion

March 28, 2019

Study Completion

June 28, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

TU(1)