Intrathecal Hydromorphone for Labor Analgesia

Not Applicable

Terminated

• Conditions: Pregnancy
• Interventions: Drug: Hyperbaric bupivacaine; Drug: Hydromorphone; Drug: Fentanyl

• Registration Number: NCT02277782
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Study Start: 2015-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Hydromorphone	Hyperbaric bupivacaine	1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
No Hydromorphone	Fentanyl	1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
Hydromorphone	Hyperbaric bupivacaine	1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Hydromorphone	Fentanyl	1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Hydromorphone	Hydromorphone	1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)

Primary Outcome Measures

Name	Time	Method
Effect on maternal temperature during labor	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Effect on efficacy of labor analgesia	2 years	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States