Evaluating abdominal size as a predictor for epidural space distance in obese patients
Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients
Ain Shams University · NCT04095117
This study is testing if measuring the size of the abdomen can better predict how far the skin is from the epidural space in obese patients who need epidural anesthesia for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT04095117 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the sagittal abdominal diameter (SAD) as a predictor of the distance from the skin to the epidural space in obese patients, comparing its accuracy to that of body mass index (BMI). Adult patients with a BMI between 30 and 39.9 kg/m², scheduled for lower abdominal or lower extremity surgeries under epidural anesthesia, will be included. The SAD will be measured at the L4-5 level, and the epidural space will be accessed using a Tuohy needle with a loss of resistance technique. Successful placement will be confirmed through characteristic pressure wave changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI between 30 and 39.9 who are undergoing elective lower extremity surgeries requiring epidural anesthesia.
Not a fit: Patients who are pregnant or have contraindications to epidural block will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of epidural anesthesia placement in obese patients, enhancing surgical outcomes and patient safety.
How similar studies have performed: While the approach of using SAD as a predictor is less common, studies have shown that alternative predictors like BMI can be effective, suggesting potential for success with this novel method.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo and 1 other locations
- Ain Shams University Hospitals — Cairo, Egypt (RECRUITING)
- Ain Shams University Hospitals — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Sameh M Hakim, MD
- Email: hakimsm@med.asu.edu.eg
- Phone: +201286824970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Epidural, Anesthesia, Headache