Fentanyl Versus Morphine in Spinal Anesthesia for Caesarian Section - Study on Analgesia, Side Ef… (NCT05533229) | Clinical Trial Compass
CompletedNot Applicable
Fentanyl Versus Morphine in Spinal Anesthesia for Caesarian Section - Study on Analgesia, Side Effects and Patient 's Satisfaction
Romania160 participantsStarted 2022-04-01
Plain-language summary
Intrathecal morphine and fentanyl are used for anesthesia and perioperative pain management in caesarian section. Despite the fact that spinal Fentanyl is better tolerated, might not be enough for postoperative pain control. Morphine offers an improved analgesia but might be not tolerated due to a higher incidence of side effects, especially nausea and vomiting.
This is a prospective, randomized, double-blind, parallel study including 80 parturients scheduled for elective CS. Spinal anesthesia is consisting in bupivacaine (7.5 - 10 mg in relation to height) and either fentanyl 25 mcg (F group) either morphine 100 mcg (m group). It will be assessed intraoperative and postoperative pain scores, the incidence of sides effects, patient's satisfaction and systemic opioids consumption.
Who can participate
Age range
18 Years – 50 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:
* ASA I-II patients
* no medical past history
* not known allergies to the used medication
* no history of chronic pain ar regular use of analgesics
* no past history of anxiety or depression
* body weight ≥ 50 kg
* elective C section indication
* single fetus
Exclusion Criteria:
* conversion from a natural delivery with/without an epidural anesthesia started
* pregnant women with psychiatric disorder;
* history of drug addiction; diagnosis of acute or chronic fetal distress; contraindication of spinal anesthesia;
* patient refusal;
* preeclamptic patients, patients who developed allergic reaction after enrolling in the study;
* refusal of the pain killers or other protocol medication prescribed;
* the necessity of surgical reintervention in the next 72 h after C-section;
* previous administration of opioids and/or other central nervous system depressants.
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
1
to assess the perioperative analgesia using Numeric Pain Scale