NCT05642234

Brief Summary

Epidural anesthesia/analgesia can be performed under various positions. In this study, the investigators aimed to compare the intervertebral and skin-epidural distances in "the sitting" and "rider" positions with the help of ultrasonography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

November 28, 2022

Last Update Submit

September 17, 2024

Conditions

Keywords

Epidural anesthesiaRider positionİntervertebral distanceSkin-epidural distance

Outcome Measures

Primary Outcomes (2)

  • Intervertebral distance

    Comparison of intervertebral distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.

    5 minutes

  • Skin - epidural distance

    Comparison of skin - epidural distance measurements with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.

    5 minutes

Interventions

In this study, we measured the intervertebral distance and skin-epidural distance with the help of ultrasonography in the thoracic and lumbar regions in sitting and rider positions.

Eligibility Criteria

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

The study is carried out in patients over 18 years of age who will undergo abdominal surgery, with ASA (American Society of Anesthesiologists) classification I-III.

You may qualify if:

  • ASA (American Society of Anesthesiologists) classification I-III

You may not qualify if:

  • Prior spinal surgery
  • Spinal deformity
  • Recent spinal and head trauma
  • Infection in the area to be measured
  • Severe hypovolemia
  • Severe edema
  • severe abdominal distention
  • Severe pain
  • Difficulty in cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (6)

  • Korkmaz Toker M, Altiparmak B, Uysal AI, Turan M, Gumus Demirbilek S. Rider sitting position widens lumbar intervertebral distance: a prospective observational study. Braz J Anesthesiol. 2023 Nov-Dec;73(6):758-763. doi: 10.1016/j.bjane.2021.03.010. Epub 2021 Apr 19.

    PMID: 33887338BACKGROUND
  • Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.

    PMID: 24141882BACKGROUND
  • Sahin T, Balaban O. Lumbar Ultrasonography for Obstetric Neuraxial Blocks: Sonoanatomy and Literature Review. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):257-267. doi: 10.5152/TJAR.2018.90277. Epub 2018 Aug 1.

    PMID: 30140531BACKGROUND
  • Khemka R, Rastogi S, Desai N, Chakraborty A, Sinha S. Comparison of ultrasound imaging in transverse median and parasagittal oblique planes for thoracic epidurals: A pilot study. Indian J Anaesth. 2016 Jun;60(6):377-81. doi: 10.4103/0019-5049.183398.

    PMID: 27330197BACKGROUND
  • Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.

    PMID: 29696117BACKGROUND
  • Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.

    PMID: 24790901BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Safak Emre Erbabacan, MD

    Istanbul University - Cerrahpasa

    STUDY CHAIR
  • Fatis Altındas, Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR
  • Cigdem Akyol Beyoglu, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR
  • Aylin Nizamoglu, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 8, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 30, 2023

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

We will share information about gender, age, height, body weight, ASA class, diagnosis, surgery, thoracic and lumbar intervertebral and skin-epidural distances measured in the rider and sitting positions

Locations