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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
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.


Condition or disease Intervention/treatment Phase
Cesarean Section Obstetric Anesthesia Drug: Intrathecal hydromorphone Phase 1

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Sedation [ Time Frame: 4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone ]
    Richmond Agitation and Sedation Score at above time points

  4. 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

  5. Infant Outcome [ Time Frame: up to 10 minutes ]
    Infant APGAR scores at 1, 5 and 10 minutes post delivery



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status classification less than or equal to 3 Elective cesarean section Able to obtain a signed consent in English Patients who are 18 years or older

Exclusion Criteria:

  • ASA greater than 3 or major medical comorbidities that are not optimized Patient refusal or contraindications to neuraxial/study drugs. Allergy to study drugs Conversion to general anesthesia Any patient who does not receive any multimodal regimen (PO acetaminophen, +/- PO ibuprofen/IV ketorolac) Any patient who is taking PO/IV opioids or buprenorphine during the current pregnancy

Information from the National Library of Medicine

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


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Shilen Thakrar, MD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02787928     History of Changes
Other Study ID Numbers: HM20005584
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents