Intrathecal Hydromorphone for Labor Analgesia (LITH)
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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
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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:
- Prolong the duration and improve the quality of analgesia in labor, and
- 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 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 |

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

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

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