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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06305260
Other study ID # STUDY00000324
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. The main questions it aims to answer are: - Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement? - Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - English Speaking - BMI (Body Mass Index) > 40 - Ability to provide informed consent and verbally disclose their medical history Exclusion Criteria: - History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement - Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural. - Minors - Adults unable to make their own decisions or with cognitive issues or developmental delays - Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Lumbar Ultrasound
Investigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement.

Locations

Country Name City State
United States MetroHealth Hospital Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epidural Redirects Total number of epidural needle redirections Day of Epidural
Secondary Total time to epidural space Total time to epidural space observed via loss of resistance. Day of Epidural
Secondary Number of attempts at a different level Number of attempts at a different lumbar level. Day of Epidural
Secondary Epidural replacement rate Includes epidurals that needed to be replaced because of failed epidural or inadequate pain relief Day of Epidural
Secondary Patient satisfaction Patient's satisfaction with epidural experience observed by a survey in post-partum 24 hours post-epidural
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