PainPhase 2NCT02096003
Intrathecal Hydromorphone for Pain Control After Cesarean Section
A Phase 2 study testing Intrathecal morphine and Intrathecal hydromorphone in people with Pain and Cesarean Section, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). 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, Cesarean Section
- What is being tested?
- Intrathecal morphine and Intrathecal hydromorphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 5 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Elective primary cesarean section
- Females age 18-40
Who cannot join
- Emergency cesarean section
- Anesthetic other than spinal
- History of chronic pain or pre-op opioid use
- Allergy to morphine or hydromorphone
- BMI>40
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Read more
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
- Conditions
- Pain, Cesarean Section
- Being tested
- Intrathecal morphine, Intrathecal hydromorphone
- Keywords
- Intrathecal hydromorphone, Intrathecal morphine, Primary cesarean section, Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
Also called Duramorph
0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
Intrathecal hydromorphoneDrug
Also called Dilaudid
50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Active comparator | 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections Receives: Drug: Intrathecal morphine |
| Intrathecal hydromorphone | Experimental | 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. Receives: Drug: Intrathecal hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Fentanyl PCA Consumption
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
Measured: at 24 hours
Secondary outcomes (4)
Time to Initial PCA Use
When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.
Measured: up to 24 hours
Pain Score
Assess pain scores on a scale of 1-5, with higher score indicating more pain.
Measured: at 24 hours
Patient Satisfaction Score
Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction
Measured: at 24 hours
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus
Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.
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 posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaakov Beilin, Icahn School of Medicine at Mount Sinai
- Investigators
- Yaakov Beilin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096003
- Sponsor's protocol ID
- GCO 13-1762
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2014
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02096003
- Acronym / sponsor ID
- GCO 13-1762
- Conditions
- Pain, Cesarean Section
- Keywords
- Intrathecal hydromorphone, Intrathecal morphine, Primary cesarean section, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | Active comparator | Drug: Intrathecal morphine0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections |
| Intrathecal hydromorphone | Experimental | Drug: Intrathecal hydromorphone50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective primary cesarean section
- Females age 18-40
Key exclusion criteria (5 listed)
- Emergency cesarean section
- Anesthetic other than spinal
- History of chronic pain or pre-op opioid use
- Allergy to morphine or hydromorphone
- BMI>40
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 |
|---|---|---|
| Intrathecal morphineAlso: Duramorph0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm. | Drug | Intrathecal morphine |
| Intrathecal hydromorphoneAlso: Dilaudid50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia. | Drug | Intrathecal hydromorphone |
Primary outcome
Post Operative Fentanyl PCA Consumption
Time frame: at 24 hours
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
4 secondary outcomes
Time to Initial PCA Use
Time frame: up to 24 hours
Pain Score
Time frame: at 24 hours
Patient Satisfaction Score
Time frame: at 24 hours
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus
Time frame: up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yaakov Beilin, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrathecal morphine and Intrathecal hydromorphone in people with Pain and Cesarean Section, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 5 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 20 Aug 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Operative Fentanyl PCA Consumption (time frame: at 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 20 Aug 2019.