Intrathecal Hydromorphone for Labor Analgesia
Information source: Emory University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor Pain
Intervention: Hydromorphone (Drug)
Phase: Phase 2
Sponsored by: Emory University
Official(s) and/or principal investigator(s):
Grant C Lynde, MD, Principal Investigator, Affiliation: Emory University
This study will investigate the dose of hydromorphone which will relieve the pain of women
in labor when delivered directly in the area around the spinal cord (i. e., intrathecal
injection). The primary objective is to determine the dose of intrathecal hydromorphone that
results in a pain score of less than 3 out of 10 thirty minutes after intrathecal injection
in 50% of women. Secondary objectives include determining this dose at five and ten minutes
after injection. Thirty women admitted to labor and delivery for planned vaginal delivery
desiring epidural placement will be consented for the study. The starting dose of
intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of
statistical analysis will be used, meaning that each subsequent dose will be dependent upon
the result obtained from the prior dose - ergo, if the initial subject has pain relief, the
second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have
pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.
After the intrathecal injection is given and the epidural is placed, visual analogue pain
scores will be assessed 60 minutes following injection. A pain score of less than three will
be a positive result. A pain score of three or greater will be a negative result. Blood
pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects
will also be assessed.
Official title: Determination of the ED50 of Intrathecal Hydromorphone in Laboring Women Using the Up-and-down Sequential Allocation Method
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Pain Score
Pain Scores, Visual Analogue Pain Scale
Pain Score, Visual Analogue Pain Scores
Minimum age: 18 Years.
Maximum age: 40 Years.
- Healthy patients
- Desires pain relief
- Any comorbidities other than obesity
Locations and Contacts
Grady Memorial Hospital, Atlanta, Georgia 30303, United States
Starting date: September 2013
Last updated: November 4, 2014