Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 pain
Started May 2013
Longer than P75 for early_phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2018
CompletedJanuary 3, 2019
January 1, 2019
4.6 years
May 28, 2013
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Scores
Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable
from Baseline to 24 Hours
Secondary Outcomes (1)
Number of Participants with Adverse Events (AEs)
up to 24 Hours
Study Arms (2)
Hydromorphone
EXPERIMENTAL100 mg, intrathecal administration
Morphine
ACTIVE COMPARATOR200 mg, intrathecal administration
Interventions
Injection of 100 mcg hydromorphone into the intrathecal space
Eligibility Criteria
You may qualify if:
- Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
- ASA status of I-III
- BMI \< 40
- Able to understand and sign informed consent
You may not qualify if:
- Severe pre-eclampsia
- Conversion to general anesthetic
- History of chronic opioid use
- Allergy to morphine, or hydromorphone
- Hyperemesis gravidarum
- Emergency case
- Patients who have an infection at the intended site of spinal insertion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grace Shih, MDlead
- Masimo Corporationcollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Shih, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
May 1, 2013
Primary Completion
December 4, 2017
Study Completion
October 22, 2018
Last Updated
January 3, 2019
Record last verified: 2019-01