Comparison of Skin - Epidural and Intervertebral Distances in Sitting and Rider Position

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05642234
Collaborator
(none)
70
1
4
17.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Epidural Ultrasonography

Detailed Description

Complication rates in epidural intervention, which can be used for both intraoperative and postoperative analgesia are higher than peripheral blocks, especially in open abdominal surgeries. In epidural intervention, correct determination of patient position, puncture site and the distance from the skin to the epidural area (skin - epidural distance) is very important in terms of preventing complications. The location of the point where the epidural intervention will be made is aimed to be determined using the anatomical surface markings in the blind technique. However, anatomical surface markings are unreliable in pregnant or obese patients and patients with anatomical variants. The use of pre-procedure ultrasonography allows obtaining information such as midline and baseline determination, skin-epidural distance measurement, increasing the success of the intervention.

The most preferred positions for epidural interventions are sitting and lateral decubitus positions. Many modifications of these positions also exist. The rider position is used in a few centers in and out of Turkey, but there is only one clinical study related to the position.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of Skin - Epidural and Intervertebral Distances Measured by Ultrasonography in Sitting and Rider Position
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Intervertebral distance [5 minutes]

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

  2. Skin - epidural distance [5 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Istanbul Fatih Turkey 34098

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Safak Emre Erbabacan, MD, Istanbul University - Cerrahpasa (IUC)
  • Study Director: Fatis Altındas, Prof., Istanbul University - Cerrahpasa (IUC)
  • Study Director: Cigdem Akyol Beyoglu, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)
  • Study Director: Aylin Nizamoglu, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nazim Ufuk Turhaner, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05642234
Other Study ID Numbers:
  • 367794
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nazim Ufuk Turhaner, Principal Investigator, Istanbul University - Cerrahpasa (IUC)

Study Results

No Results Posted as of Dec 8, 2022