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
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Intrathecal Hydromorphone for Labor Analgesia|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: No Hydromorphone
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
Drug: Hyperbaric bupivacaine
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Other Name: Dilaudid
Drug: Hyperbaric bupivacaine
- 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.
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|