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RecruitingNCT04095117

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
135 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEpidural blockEpidural 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.

Timeline

Start date
2019-07-01
Primary completion
2025-01-01
Completion
2025-07-01
First posted
2019-09-19
Last updated
2024-07-30

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04095117. Inclusion in this directory is not an endorsement.