CompletedPhase 4

IV Ketorolac on Platelet Function Post-Cesarean Delivery

United States40 participantsStarted 2021-01-18

Plain-language summary

Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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 * Undergoing routine, scheduled cesarean section * Gestation \>37 weeks * Singleton gestation * Intraoperative anesthesia - 1.5 ml of intrathecal bupivicaine 0.75%, 25mcg of intrathecal fentanyl and 250 mcg of intrathecal morphine via Spinal or Combined Spinal Epidural Exclusion Criteria: * Pre-eclampsia with severe features or HELLP * Allergy to NSAIDs * Pre-existing bleeding disorder * Other major risk factor for postpartum hemorrhage (placenta accreta, large uterine fibroid) * Chronic kidney disease * Plt count less than 100k * Gastric ulcer or gastric bleeding * Pre-existing uterine bleeding or disseminated intravascular coagulation * Patient or Obstetrician refusal * Intraoperative exclusion criteria - Postpartum hemorrhage (EBL \>1000 ml) or unplanned intraoperative extension of surgery

What they're measuring

Platelet Aggregometry Light Transmission

Timeframe: 15 minutes after dosing of placebo or ketorolac

Trial details

NCT IDNCT03805607

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-03