NCT02787928

Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions. Parturients present a unique challenge for the anesthesiologist as the mother has to care not only for herself, but also for the newborn postpartum. While intrathecal opioids provide adequate pain relief, they do so at the cost of bothersome side effects for patients, such as pruritus and nausea/vomiting. Intrathecal hydromorphone has started to be explored as a new option for intrathecal analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia after cesarean delivery. Additionally they showed no difference in side effect profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were inconclusive, but the dosage of hydromorphone was reported to be without adverse effects. Virginia Commonwealth University Health Systems has successfully instituted the use of intrathecal morphine with superior analgesia but with undesired side effects, most notably pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative options for post cesarean section analgesia. The investigators are interested in determining the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our institution has never utilized intrathecal hydromorphone for our patient population, it has been studied at various other institutions where it has been found to be safe and efficacious with an acceptable side effect profile.

Conditions

• Cesarean Section
• Obstetric Anesthesia

Interventions

Type	Name	Description
DRUG	Intrathecal hydromorphone	Intrathecal hydromorphone will be administered in an up/down dosage fashion. A successful dose will be defined as a patient not requiring additional narcotic pain medication outside of the standard VCU order set, which includes PRN oxycodone 5 and 10 mg every 4 hours and a one time PRN 1 mg hydromorphone IV. Failure of a dose will be if patient requires additional narcotic pain medication outside of these parameters

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2016-06-01
• Last updated: 2018-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study