Intrathecal Hydromorphone for Labor Analgesia

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

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2019-12-31

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:

1. Prolong the duration and improve the quality of analgesia in labor, and
2. Decrease the incidence of epidural-associated temperature increase in labor.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No Hydromorphone

1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.

Group Type ACTIVE_COMPARATOR

Hyperbaric bupivacaine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Hydromorphone

1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)

Group Type EXPERIMENTAL

Hydromorphone

Intervention Type DRUG

Hyperbaric bupivacaine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Interventions

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Hydromorphone

Intervention Type DRUG

Hyperbaric bupivacaine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Other Intervention Names

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Dilaudid

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No