Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-10-22

Brief Summary

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The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

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Detailed Description

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Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.

One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hydromorphone

100 mg, intrathecal administration

Group Type EXPERIMENTAL

Hydromorphone

Intervention Type DRUG

Injection of 100 mcg hydromorphone into the intrathecal space

Morphine

200 mg, intrathecal administration

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Injection of 200 mcg of intrathecal morphine

Interventions

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Hydromorphone

Injection of 100 mcg hydromorphone into the intrathecal space

Intervention Type DRUG

Morphine

Injection of 200 mcg of intrathecal morphine

Intervention Type DRUG

Other Intervention Names

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DILAUDID® INJECTION Duramorph

Eligibility Criteria

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Inclusion Criteria

* Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
* ASA status of I-III
* BMI \< 40
* Able to understand and sign informed consent

Exclusion Criteria

* Severe pre-eclampsia
* Conversion to general anesthetic
* History of chronic opioid use
* Allergy to morphine, or hydromorphone
* Hyperemesis gravidarum
* Emergency case
* Patients who have an infection at the intended site of spinal insertion

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes