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Intrathecal Hydromorphone for Labor Analgesia (LITH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277782
Recruitment Status : Unknown
Verified January 2018 by Dominique Arce, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dominique Arce, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Hydromorphone Drug: Hyperbaric bupivacaine Drug: Fentanyl Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Intrathecal Hydromorphone for Labor Analgesia
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
 Drug: Hyperbaric bupivacaine
Drug: Fentanyl
Experimental: Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
 Drug: Hydromorphone
Other Name: Dilaudid

Drug: Hyperbaric bupivacaine
Drug: Fentanyl


Outcome Measures
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Primary Outcome Measures :
  1. Effect on maternal temperature during labor [ Time Frame: 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 :
  1. Effect on efficacy of labor analgesia [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277782


Contacts
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Contact: Dominique Arce, MD 617-732-8220 DArce@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Dominique Arce, MD    617-732-8220    DArce@partner.org   
Principal Investigator: Dominique Arce, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
More Information
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Responsible Party: Dominique Arce, Instructor of Anaesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02277782    
Other Study ID Numbers: 2014P002384
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Dominique Arce, Brigham and Women's Hospital:
Labor
Analgesia
Additional relevant MeSH terms:
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Fentanyl
Hydromorphone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General