NCT04092478

Brief Summary

The most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion. In a study by Martha L Walker et al., The maximum extension of the knees, adduction of the hip, and a modified sitting position with the back flexion, ie, the abdominal crunch position, were found to be effective in increasing the flexion of the lumbar spine. In our study, we aimed to measure the interspinal distance with the abdominal crunch position with the help of ultrasonography (USG) and to compare the interspinal distance with the measurements obtained in traditional positions (sitting position and lateral decubitus).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 13, 2019

Last Update Submit

September 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inter spinal distance

    Increasing of the Inter spinal distance

    Through study completion, an average of 6 months.

Study Arms (3)

Traditional Sitting Position

We are going to use the Traditional Sitting Position on each patients.

Other: Spinal Anesthesia Position

Lateral Decubitis Position

We are going to use the Lateral Decubitis Position on each patients.

Other: Spinal Anesthesia Position

Abdominal Crunch Position

We are going to use the Abdominal Crunch Position on each patients.

Other: Spinal Anesthesia Position

Interventions

The patient positions during the spinal anesthesia

Abdominal Crunch PositionLateral Decubitis PositionTraditional Sitting Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.

You may qualify if:

  • Patients over the age of 18
  • Undergo elective surgery

You may not qualify if:

  • Patients with vertebral anomaly
  • Patient with not communicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasin Tire

Konya, Meram, 42090, Turkey (Türkiye)

Location

Study Officials

  • Yasin Tire, MD

    Konya Meram State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 17, 2019

Study Start

October 23, 2019

Primary Completion

January 8, 2020

Study Completion

January 31, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations