- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366307
Management of Indwelling Labor Epidural Catheters for Cesarean Delivery
January 16, 2026 updated by: Baylor Research Institute
Management of Indwelling Labor Epidural Catheters and Pain During Cesarean Delivery: a Prospective Single-center Patient-reported Outcome Study
This is a prospective observational study that will survey patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery.
We hypothesize that patients who had removal of indwelling labor epidural catheters and had a new neuraxial anesthetic technique attempted will have a lower incidence of self-reported pain during cesarean delivery compared to patients who had top up of their indwelling labor epidural catheters.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael P Hofkamp, M.D.
- Phone Number: 254-724-3370
- Email: Michael.Hofkamp@bswhealth.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients will be identified as potential study participants if they have a cesarean delivery at Baylor Scott & White Medical Center-Temple from January 1, 2026 through December 31, 2025.
Description
Inclusion Criteria:
- ages 18-50 years
- had cesarean delivery at Baylor Scott & White Medical Center from January 1, 2026 through December 31, 2026
- Fluent in the English language (our catastrophizing survey is validated in English language only)
- Can provide their own consent
- Identifies as Black or African American only, Hispanic, or White or Caucasian only
- had administration of local anesthetic through indwelling labor epidural or removal of indwelling labor epidural followed by single injection spinal or combined spinal epidural
Exclusion Criteria:
- less than 18 years old, older than 50 years old
- had cesarean delivery at Baylor Scott & White Medical Center before January 1, 2026 or after December 31, 2026
- Employee of Baylor Scott & White Health labor and delivery unit
- Student of a school that performs clinical rotations at Baylor Scott & White Medical Center-Temple
- Incarcerated at the time of study enrollment
- Underwent scheduled cesarean hysterectomy
- Underwent cesarean delivery with general anesthesia as either the primary anesthetic technique or had conversion to general anesthesia because of failure of neuraxial anesthesia
- Admitted to the intensive care unit immediately following cesarean delivery
- Did not have intrathecal morphine or intrathecal fentanyl if receiving spinal anesthesia
- Had anesthesia for an attempted external cephalic version within 24 hours of cesarean delivery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cesarean delivery patients
Patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain during cesarean delivery
Time Frame: Patients will be asked this question once 24-72 hours after their cesarean delivery.
|
Patients will answer "yes" or "no" to whether they experienced pain during their cesarean delivery.
|
Patients will be asked this question once 24-72 hours after their cesarean delivery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael P Hofkamp, M.D., Baylor Scott & White Medical Center-Temple
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 16, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 025-604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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