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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095117
• Other study ID #: FMASU MD 153/2019
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: Sameh M Hakim, MD
• Phone: +201286824970
• Email: hakimsm[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural; Anesthesia, Headache
• Headache
• Obesity

Intervention

Procedure:
• Epidural block
Epidural catheter will be inserted at the L3-L4 or L4-L5 interspace in obese subjects scheduled for surgery on the lower extremities under epidural anesthesia. The sagittal abdominal diameter, BMI and skin to epidural space distance will be recorded.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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