Intrathecal Hydromorphone for Labor Analgesia

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will: Prolong the duration and improve the quality of analgesia in labor, and Decrease the incidence of epidural-associated temperature increase in labor.

Official Title
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Intrathecal Hydromorphone for Labor Analgesia

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Hyperbaric bupivacaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks). Exclusion Criteria: Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Hydromorphone<br>1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline. | Drug: Hyperbaric bupivacaine<br> <br> Drug: Fentanyl<br> <br> |
| Experimental: Hydromorphone<br>1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml) | Drug: Hydromorphone<br> <br> * Other names: Dilaudid;Drug: Hyperbaric bupivacaine<br> <br> Drug: Fentanyl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on maternal temperature during labor | The primary outcome measure will be the incidence of maternal temperature increase, defined as an increase in maternal temperature by 1 degree celsius over the baseline temperature recorded prior to the onset of epidural analgesia. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on efficacy of labor analgesia | The secondary outcome measure will be the duration of intrathecal analgesia. Additional outcome measures include the quality of analgesia as recorded by the Visual Analogue Scale score and the need for additional top-ups within 90 min of epidural placement. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Analgesia