PainEarly Phase 1NCT01866254
Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
A Early Phase 1 study testing Hydromorphone and Morphine in people with Pain, run by Grace Shih, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Hydromorphone and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 22 Oct 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the detailed description
Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.
One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called DILAUDID® INJECTION
Injection of 100 mcg hydromorphone into the intrathecal space
MorphineDrug
Also called Duramorph
Injection of 200 mcg of intrathecal morphine
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone | Experimental | 100 mg, intrathecal administration Receives: Drug: Hydromorphone |
| Morphine | Active comparator | 200 mg, intrathecal administration Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from Baseline to 24 Hours
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs)
Patients will be monitored hourly for first 12 hours followed by every 2 hours for the next 12 hours. Masimo acoustic monitor will monitor respirations.
Measured: up to 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completion4 Dec 2017
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Shih, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Sponsor-investigator, Grace Shih, MD, University of Kansas Medical Center
- Investigators
- Grace Shih, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866254
- Sponsor's protocol ID
- 13527
- Status last verified
- Jan 2019
- First submitted
- 28 May 2013
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT01866254
- Acronym / sponsor ID
- 13527
- Conditions
- Pain
- Keywords
- Hydromorphone, Morphine, cesarean delivery, pain management, respiratory depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Grace Shih, MDUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- May 2013
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.
One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone | Experimental | Drug: Hydromorphone100 mg, intrathecal administration |
| Morphine | Active comparator | Drug: Morphine200 mg, intrathecal administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Severe pre-eclampsia
- Conversion to general anesthetic
- History of chronic opioid use
- Allergy to morphine, or hydromorphone
- Hyperemesis gravidarum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: DILAUDID® INJECTIONInjection of 100 mcg hydromorphone into the intrathecal space | Drug | Hydromorphone |
| MorphineAlso: DuramorphInjection of 200 mcg of intrathecal morphine | Drug | Morphine |
Primary outcome
Change in Pain Scores
Time frame: from Baseline to 24 Hours
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
1 secondary outcome
Number of Participants with Adverse Events (AEs)
Time frame: up to 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Shih, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydromorphone and Morphine in people with Pain, run by Grace Shih, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Scores (time frame: from Baseline to 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.