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

Phase 1

Terminated

• Conditions: Obstetric Anesthesia; Cesarean Section
• Interventions: Drug: Intrathecal hydromorphone

• Registration Number: NCT02787928
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrathecal Dilaudid	Intrathecal hydromorphone	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.

Primary Outcome Measures

Name	Time	Method
Narcotic Pain Medication	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

Name	Time	Method
Infant Outcome	up to 10 minutes	Infant APGAR scores at 1, 5 and 10 minutes post delivery
Nausea	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	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	4, 8, 12, 18 and 24 hours after placement of intrathecal hydromorphone	Richmond Agitation and Sedation Score at above time points
Pain	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States