Intrathecal Hydromorphone for Labor Analgesia

NCT02277782 | Terminated DMC

• 1 other identifier: 2014P002384
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy

Keywords

Labor; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect on efficacy of labor analgesia

  2 years

Study Arms (2)

No Hydromorphone

ACTIVE COMPARATOR

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

Drug: Hyperbaric bupivacaine; Drug: Fentanyl

Hydromorphone

EXPERIMENTAL

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

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

Interventions

Hydromorphone DRUG

Also known as: Dilaudid

Hydromorphone

Hyperbaric bupivacaine DRUG

Hydromorphone; No Hydromorphone

Fentanyl DRUG

Hydromorphone; No Hydromorphone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Hydromorphone; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Anaesthesia

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: September 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

US (1)