Two Dose Epidural Morphine for Post-cesarean Analgesia (NCT01844206) | Clinical Trial Compass
TerminatedPhase 4
Two Dose Epidural Morphine for Post-cesarean Analgesia
Stopped: Slow recruitment of subjects
United States5 participantsStarted 2013-06
Plain-language summary
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
Who can participate
Age range
18 Years – 45 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:
* Women undergoing cesarean section under epidural anesthesia.
Exclusion Criteria:
* Emergent cesarean section
* Coagulopathy
* Failed epidural anesthesia or patchy block
* General anesthesia
* Use of epidural chloroprocaine
* Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
* Severe opioid side effects
* History of chronic opioid use
* History of chronic pain
* History of obstructive sleep apnea
* Morbid obesity (Body Mass Index (BMI)\>45 kg/m2)
* Height under 4' 10" (147 cm)
* Documented dural puncture by the epidural (Tuohy) needle
* Preeclampsia
* Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
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.
1This trial was terminated before it finished — do you know why it was stopped early, and does that affect whether the two-dose epidural morphine approach is considered safe or effective for post-cesarean pain?
2The study was specifically looking at how much extra IV morphine patients needed in the second 24 hours after surgery — what does that tell us about how well epidural morphine controls pain after a C-section, and how does that compare to what you'd recommend for me?
3Since this was a Phase 4 trial testing an already-approved use of epidural morphine, does that mean we have a reasonable amount of safety data on this approach, or are there still risks I should be aware of given that it was terminated?
4The trial was studying morphine adverse reactions alongside pain relief — what are the most common or serious side effects of epidural morphine after a C-section that I should watch out for and discuss with my care team?
5Given that this trial was terminated and may not have produced complete results, is there other completed research or a standard-of-care approach you'd recommend for managing my pain after a cesarean section instead?
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
1
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery