CompletedPhase 4

Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery

United States70 participantsStarted 2016-05

Plain-language summary

In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.

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: * Patients undergoing a scheduled or non-scheduled, non-urgent primary or repeat Cesarean delivery between 37-42 weeks gestational age, * Viable singleton intra-uterine pregnancy, * Patients undergoing a scheduled or unscheduled, non-emergent/non-urgent Cesarean delivery for placenta previa or vasa previa, * Neuraxial anesthesia with combined spinal-epidural placed for surgery, * Patients must be 18 years or older as well as willing and able to provide informed consent. Exclusion Criteria: * Patients unable or unwilling to provide informed consent, * Urgent or emergent Cesarean delivery * Multiple fetal gestations (\>1 intrauterine pregnancy), * Cesarean delivery for bleeding such as placental abruption or actively bleeding placenta previa or vasa previa, * Contraindication to NSAID use eg: allergy, chronic renal disease, * Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome), * Platelets \<100k, * History of peptic ulcer disease, * Inherited or acquired coagulopathies or bleeding disorder, (disseminated intravascular coagulopathy, hemophilia), * Suspected or proven placenta accreta, increta or percreta, * Inability to receive epidural morphine, * Diagnosed chronic pain disorder on chronic adjunct or opioid analgesia, * Use of general anesthesia during procedure. Intraoperative exclusion criteria: \- EBL \> 1000 ml prior to cord clamp

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

Estimated Blood Loss (EBL)

Timeframe: Immediately post-op

Trial details

NCT IDNCT02509312

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2022-03-02

View on ClinicalTrials.gov More Analgesia, Obstetrical trials