TerminatedNot Applicable

Epidural Technique: Does it Really Matter to the Patient?

Stopped: This study was terminated early because of shortage of supplies with no foreseeable future of when they will be back in stock.

United States57 participantsStarted 2018-05-26

Plain-language summary

The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female parturient at Grady Memorial Hospital must meet one of the following: * Parturient having a scheduled or elective cesarean section * Parturient not having primary cesarean-section * At least 18 years of age * Subject has signed the informed consent Exclusion Criteria: * Parturient who is unable or unwilling to sign the consent form * Parturient having primary cesarean section * Parturient with known complex cardiac disease (ex…aortic/mitral stenosis, aortic aneurysms, congenital heart disease with residual defects…etc) * Parturient with any contraindication to neuraxial anesthesia such as coagulopathy, infection, or patient refusal * Parturient having a fourth or more cesarean section

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group

Timeframe: 1 hour after procedure

Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.

Timeframe: 1 hour after procedure

Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group

Timeframe: 1 hour after procedure

Trial details

NCT IDNCT03539796

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-17

View on ClinicalTrials.gov More Anesthesia trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group

Timeframe: 1 hour after procedure

Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.

Timeframe: 1 hour after procedure

Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group

Timeframe: 1 hour after procedure