Management of Indwelling Labor Epidural Catheters for Cesarean Delivery

NCT07366307 | Not Yet Recruiting

• 1 other identifier: 025-604
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intraoperative Pain

Keywords

cesarean section; pain; labor epidural catheter; top up

Outcome Measures

Primary Outcomes (1)

• Pain during 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.

Study Arms (1)

Cesarean delivery patients

Patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Related Publications (1)

• Litman J, Bates R, Lindheim SR, Sharpe EE, Ehrig JC, Hofkamp MP. Patient and clinical characteristics associated with pain during cesarean delivery: a prospective single-center patient-reported outcome study. Int J Obstet Anesth. 2025 Feb;61:104324. doi: 10.1016/j.ijoa.2024.104324. Epub 2025 Jan 10.

  PMID: 39827661 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael P Hofkamp, M.D.

  Baylor Scott & White Medical Center-Temple

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P Hofkamp, M.D.

CONTACT

254-724-3370; Michael.Hofkamp@bswhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share