CompletedPhase 2/3

Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

Tunisia200 participantsStarted 2015-01-01

Plain-language summary

Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.

Who can participate

Age range

18 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: * Pregnant in singleton pregnancy with gestational age \> 34 weeks * American society of anesthesiologists (ASA) physical status I-II. Exclusion Criteria: * history of gastrointestinal disorders predisposing to bleeding disorders such as ulcerative colitis, * Crohn's disease, * gastrointestinal cancers or diverticulitis, * an active peptic ulcer, * an inflammatory gastrointestinal disorder or a gastrointestinal haemorrhage, * parturients who present preeclampsia, * premature delivery (\<32 weeks), * constitutional or acquired coagulopathy, * An antecedent of hemorrhage of the delivery, * a hemorrhagic complication postoperatively, * Anemia (hemoglobin less than 8g / 100ml), * conversion of spinal anesthesia into general anesthesia, * women with severe medical conditions: renal failure (preoperative creatinine clearance \<30ml / min), heart or liver failure.

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

Visual Analogue Scale (VAS) pain

Timeframe: 24 hours postoperative

Trial details

NCT IDNCT03626753

SponsorCentre de Maternité de Monastir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06-30

View on ClinicalTrials.gov More Cesarean Section; Complications, Wound, Infection (Following Delivery) trials