Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System
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|ClinicalTrials.gov Identifier: NCT02787928|
Recruitment Status : Terminated (Lack of reliable supply of of preservative free IV Hydromorphone for intrathecal use.)
First Posted : June 1, 2016
Last Update Posted : April 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section Obstetric Anesthesia||Drug: Intrathecal hydromorphone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: Intrathecal Dilaudid
This will be a prospective up/down dosage study. After obtaining informed consent, eligible participants will be part of an up/down dose titration study. This first phase of our study will be conducted using intrathecal (spinal) hydromorphone to determine an appropriate dose range for our study population. Study drug dose will initially be 40 mcg. The only deviation from the current standard of care will be that patients will be given hydromorphone intrathecally instead of morphine. The rest of the care provided will be standard of care and per current practices at VCU labor and delivery floor.
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
- Narcotic Pain Medication [ Time Frame: 12 hours post administration of intrathecal hydromorphone ]Dose failure defined as requiring more than oxycodone 5 or 10 mg q 4 hours and a 1x PRN of IV hydromorphone
- Nausea [ Time Frame: 4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone ]Rated on Numerical rating scale 0 -10 and by amount of anti-emetic medication required (ondansetron)
- Pruritus [ Time Frame: 4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone ]Rated on numerical rating scale 0 - 10, and by amount of anti-pruritic medication required (nalbuphine, benadryl)
- Sedation [ Time Frame: 4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone ]Richmond Agitation and Sedation Score at above time points
- Pain [ Time Frame: 4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone ]Pain score on numeric rating scale, 0 - 10 at above time points, total amount of narcotic pain medication required
- Infant Outcome [ Time Frame: up to 10 minutes ]Infant APGAR scores at 1, 5 and 10 minutes post delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787928
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Shilen Thakrar, MD||Virginia Commonwealth University|