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Not yet recruiting NCT07366307

Management of Indwelling Labor Epidural Catheters for Cesarean Delivery

Observational Intraoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intraoperative Pain. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Management of Indwelling Labor Epidural Catheters and Pain During Cesarean Delivery: a Prospective Single-center Patient-reported Outcome Study

Overview

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.

Primary outcome measures

  • Pain during cesarean delivery [Time frame: Patients will be asked this question once 24-72 hours after their cesarean delivery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07366307 · 025-604

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗