Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients

The aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor

Study Overview

• Status: Recruiting
• Conditions: Obesity; Epidural; Anesthesia, Headache
• Intervention / Treatment: Procedure: Epidural block

Detailed Description

Adult patients from either sex with BMI from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. Pregnant women will be excluded.

The sagittal abdominal diameter (SAD), which is the anteroposterior diameter of the abdomen in the supine position at L4-5 level will be measured in all subjects along with the BMI prior to epidural placement.

The epidural space will be accessed at the L3-L4 or L4-L5 interspace with a 16-G or 18-G Tuohy needle using a loss of resistance to saline technique. The proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by Arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations.

The distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded.

An epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (Bromage score 3-4).

Successful placement of the epidural needle will be considered if the following two criteria are fulfilled: (1) Detection of the characteristic epidural pressure wave form as described above and (2) Establishment of adequate sensory and motor block.

Simple linear regression will be used to deduce an equation relating the skin to epidural space distance to the sagittal abdominal diameter or to the BMI.

• Study Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Sameh M Hakim, MD; Phone Number: +201286824970; Email: hakimsm@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Hany Eldhahaby, MD; Phone Number: +201227463000; Email: hanyzahaby@hotmail.com
  • Cairo, Egypt, 11517
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Hany Eldhahaby, MD; Phone Number: +201227463000; Email: hanyzahaby@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with BMI of 30 to 39.9 kg/m2 who are scheduled for lower extremity surgery under epidural anesthesia.

Description

Inclusion Criteria:

• Age 18 years or older
• BMI 30 to 39.9
• Either sex
• Elective surgery on lower extremities performed under epidural anesthesia

Exclusion Criteria:

• Pregnant women
• Contraindications to epidural block

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance	Actual skin to epidural space distance will be determined and regressed on the sagittal abdominal diameter to determine accuracy of the latter for prediction of the former	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the BMI for prediction of the skin to epidural space distance	Actual skin to epidural space distance will be determined and regressed on the BMI to determine accuracy of the latter for prediction of the former	18 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: FMASU MD 153/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No