Post-operative PainPhase 4NCT06114121
Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.
A Phase 4 study testing erector spinae plane block (ESP), Duramorph and Ropivacaine in people with Post-operative Pain, run by University of Miami.
Trial summary
The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- erector spinae plane block (ESP), Duramorph and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2024to 10 Sep 2024
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Able to consent
- BMI<35
Who cannot join
- Adults unable to consent
- BMI>35
- Individuals <18 years of age at time of admission
- Individuals taking anticoagulant medications
- Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
- Pre-existing chronic pain or pain disorder diagnosis
- Conversion from neuraxial to general anesthesia
- Prisoners
About this study
Official title: Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain
The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section
- Conditions
- Post-operative Pain
- Being tested
- erector spinae plane block (ESP), Duramorph, Ropivacaine, Bupivacaine Injection
- Keywords
- erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane block (ESP)Procedure or surgery
nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.
DuramorphDrug
100 micrograms (mcg) of morphine administered in the spinal medications one time.
RopivacaineDrug
Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.
Bupivacaine InjectionDrug
Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block | Experimental | participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block Receives: Procedure: erector spinae plane block (ESP); Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection |
| standard of care | Experimental | participants in this group will receive the standard of care treatment and will be in this group for up to 9 months. Receives: Drug: Duramorph; Drug: Ropivacaine; Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative opioid analgesic medication
measurement (milligrams)
Measured: up to 24 hours
Secondary outcomes (3)
change in post-operative pain medication by visual analog scale
Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain)
Measured: baseline, up to 24 hours
number of minutes to first use of rescue medication
the number of minutes calculated using the kaplan-meier. Calculated using the number of patients that did not need the rescue analgesic at the start of each day post-surgery, and the number of patients who needed the rescue analgesic.
Measured: up to 24 hours
obstetric quality of recovery scale
responses range from 0-10. zero is strongly agree, strongly disagree.
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 posted2 Nov 2023
- Study start10 Jul 2024 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Why it stopped: Study will no longer be conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reine Zbeidy, University of Miami
- Investigators
- Reine Zbeidy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114121
- Sponsor's protocol ID
- 20230857
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain
- ClinicalTrials.gov ID
- NCT06114121
- Acronym / sponsor ID
- 20230857
- Conditions
- Post-operative Pain
- Keywords
- erector spinae plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will no longer be conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- 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 objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block | Experimental | Procedure: erector spinae plane block (ESP), Drug: Duramorph, Drug: Ropivacaine, Drug: Bupivacaine Injectionparticipants will be in this group for up to 9 months and receive erector spinae plane (ESP) block |
| standard of care | Experimental | Drug: Duramorph, Drug: Ropivacaine, Drug: Bupivacaine Injectionparticipants in this group will receive the standard of care treatment and will be in this group for up to 9 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to consent
- BMI<35
Key exclusion criteria (8 listed)
- Adults unable to consent
- BMI>35
- Individuals <18 years of age at time of admission
- Individuals taking anticoagulant medications
- Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
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 |
|---|---|---|
| erector spinae plane block (ESP)nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care. | Procedure or surgery | erector spinae plane block |
| Duramorph100 micrograms (mcg) of morphine administered in the spinal medications one time. | Drug | erector spinae plane block, standard of care |
| RopivacaineRopivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose. | Drug | erector spinae plane block, standard of care |
| Bupivacaine InjectionBupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time. | Drug | erector spinae plane block, standard of care |
Primary outcome
post-operative opioid analgesic medication
Time frame: up to 24 hours
measurement (milligrams)
3 secondary outcomes
change in post-operative pain medication by visual analog scale
Time frame: baseline, up to 24 hours
number of minutes to first use of rescue medication
Time frame: up to 24 hours
obstetric quality of recovery scale
Time frame: up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Reine Zbeidy, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing erector spinae plane block (ESP), Duramorph and Ropivacaine in people with Post-operative Pain, run by University of Miami.
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 8 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 opioid analgesic medication (time frame: up 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 19 Sep 2024.