Intraoperative PainNCT07366307
Management of Indwelling Labor Epidural Catheters for Cesarean Delivery
An observational study of Intraoperative Pain, run by Baylor Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Pain
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Intraoperative Pain
- Keywords
- cesarean section, pain, labor epidural catheter, top up
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean delivery patients | Patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during cesarean delivery
Patients will answer "yes" or "no" to whether they experienced pain during their cesarean delivery.
Measured: Patients will be asked this question once 24-72 hours after their cesarean delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative PainStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael P Hofkamp, M.D., Principal investigator, Baylor Scott & White Medical Center-Temple
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366307
- Sponsor's protocol ID
- 025-604
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39827661
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Indwelling Labor Epidural Catheters and Pain During Cesarean Delivery: a Prospective Single-center Patient-reported Outcome Study
- ClinicalTrials.gov ID
- NCT07366307
- Acronym / sponsor ID
- 025-604
- Conditions
- Intraoperative Pain
- Keywords
- cesarean section, pain, labor epidural catheter, top up
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean delivery patients | – | –Patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 39827661Litman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael P Hofkamp, M.D. principal investigator
Baylor Scott & White Medical Center-Temple
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Pain, run by Baylor Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael P Hofkamp, M.D. (254-724-3370, Michael.Hofkamp@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during cesarean delivery (time frame: Patients will be asked this question once 24-72 hours after their cesarean delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.