Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Study Overview
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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.

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.

Official Title
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Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Conditions
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Pain

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Morphine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydromorphone<br>100 mg, intrathecal administration | Drug: Hydromorphone<br>* Injection of 100 mcg hydromorphone into the intrathecal space<br>* Other names: DILAUDID® INJECTION;|
| Active Comparator: Morphine<br>200 mg, intrathecal administration | Drug: Morphine<br>* Injection of 200 mcg of intrathecal morphine<br>* Other names: Duramorph;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Scores | Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable | from Baseline to 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | Patients will be monitored hourly for first 12 hours followed by every 2 hours for the next 12 hours. Masimo acoustic monitor will monitor respirations. | up to 24 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydromorphone, cesarean delivery, pain management, respiratory depression, Morphine