Intrathecal Hydromorphone for Labor Analgesia (LITH)

Mass General Brigham

Status: Terminated

Conditions: Pregnancy

Treatments: Drug: Hydromorphone; Drug: Hyperbaric bupivacaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02277782

2014P002384

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

No Hydromorphone

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Hyperbaric bupivacaine

Hydromorphone

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Hyperbaric bupivacaine

Drug: Hydromorphone