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

NCT04095117 | Recruiting

• 1 other identifier: FMASU MD 153/2019
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Obesity; Epidural; Anesthesia, Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of the BMI for prediction of the skin to epidural space distance

  18 months

Interventions

Epidural block PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Contraindications to epidural block

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University Hospitals

Cairo, 11517, Egypt

RECRUITING

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity; Headache

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Sameh M Hakim, MD

CONTACT

+201286824970; hakimsm@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Intensive Care and Pain Management

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (2)