Cesarean SectionEarly Phase 1NCT03427463
Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.
A Early Phase 1 study testing receiving 0.1 mg IT morphine and recieving 0.05 mg IT morphine in people with Cesarean Section, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- receiving 0.1 mg IT morphine and recieving 0.05 mg IT morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 3 Aug 2023
- Phase
- Early Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any parturient 18 years of age or older
- undergoing elective cesarean delivery under spinal anesthesia
- able to consent to the study and participate in the follow-up.
Who cannot join
- any known allergy to morphine
- general anesthesia
- urgent or emergent cases
- any bleeding diathesis or other coagulopathy
- known G6PD deficiency
- any known liver disease
Show all 16Show fewer
- known alcohol abuse or dependence
- HELLP syndrome
- thrombocytopenia or known platelet dysfunction
- history or active gastrointestinal bleeding
- acute kidney injury or chronic renal insufficiency
- contraindication/refusal to spinal anesthestic
- chronic pain
- chronic narcotic use
- illicit drug use
- allergy to any study related medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.
- Conditions
- Cesarean Section
- Being tested
- receiving 0.1 mg IT morphine, recieving 0.05 mg IT morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receiving 0.1 mg IT morphineDrug
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
recieving 0.05 mg IT morphineDrug
Patients will receive 0.05 mg of intrathecal morphine
| Study group | Role | What they receive |
|---|---|---|
| receiving 0.1 mg IT morphine | Active comparator | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine Receives: Drug: receiving 0.1 mg IT morphine |
| recieving 0.05 mg IT morphine | Experimental | Patients will receive 0.05 mg of intrathecal morphine Receives: Drug: recieving 0.05 mg IT morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.
Measured: 24 hours
Secondary outcomes (5)
Time to First Ambulation After C-section
This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated.
Measured: up to 48 hours
Opioid Medication Given During the Participant's Hospital Stay.
This outcome looks at whether or not any opioid medications were given during the participant's hospital stay, reporting the number of subjects who received opioid pain medication during the admission.
Measured: From the time of the procedure through discharge, up to 48 hours.
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
Subjective pain with ambulation reported by participants using visual analogue scales (VAS) ranging from 0-100 at the 24-hour post-op time point and 48-hour post-op time point. The lower the number, the better the outcome.
Measured: 24-hours post operatively and 48-hours post operatively
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
The presence of opiate side effects (nausea, vomiting, and pruritus) was evaluated from 0-24 hours post-op.
Measured: 24 hours post operavtively
Overall Patient Satisfaction With Pain Control
Patients were asked to mark their satisfaction with pain control using a Visual Analog Scale (VAS) from 0-100. The higher the number, the more satisfied they were with the post-op pain control
Measured: 48 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start16 Jan 2018
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
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 Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted as a randomized controlled single-blinded clinical trial with patients being randomized to receive either 0.1 or 0.05 mg of IT morphine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Hatter, MD, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427463
- Sponsor's protocol ID
- Pro00072393
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2018
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
- ClinicalTrials.gov ID
- NCT03427463
- Acronym / sponsor ID
- Pro00072393
- Conditions
- Cesarean Section
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 19 Dec 2024
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 the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be conducted as a randomized controlled single-blinded clinical trial with patients being randomized to receive either 0.1 or 0.05 mg of IT morphine.
| Arm | Type | Receives |
|---|---|---|
| receiving 0.1 mg IT morphine | Active comparator | Drug: receiving 0.1 mg IT morphinePatients will receive the standard of care dose 0.1 mg of intrathecal morphine |
| recieving 0.05 mg IT morphine | Experimental | Drug: recieving 0.05 mg IT morphinePatients will receive 0.05 mg of intrathecal morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any parturient 18 years of age or older
- undergoing elective cesarean delivery under spinal anesthesia
- able to consent to the study and participate in the follow-up.
Key exclusion criteria (16 listed)
- any known allergy to morphine
- general anesthesia
- urgent or emergent cases
- any bleeding diathesis or other coagulopathy
- known G6PD deficiency
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 |
|---|---|---|
| receiving 0.1 mg IT morphinePatients will receive the standard of care dose 0.1 mg of intrathecal morphine | Drug | receiving 0.1 mg IT morphine |
| recieving 0.05 mg IT morphinePatients will receive 0.05 mg of intrathecal morphine | Drug | recieving 0.05 mg IT morphine |
Primary outcome
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery.
Time frame: 24 hours
This is defined as the number of hours until the first rescue dose of medication was given to participants within the first 24-hours post-op.
5 secondary outcomes
Time to First Ambulation After C-section
Time frame: up to 48 hours
Opioid Medication Given During the Participant's Hospital Stay.
Time frame: From the time of the procedure through discharge, up to 48 hours.
Subjective Pain Rating Using Visual Analogue Scales (VAS) Ranging From 0-100.
Time frame: 24-hours post operatively and 48-hours post operatively
Presence of Opiate Side Effects (Nausea, Vomiting, and Pruritus)
Time frame: 24 hours post operavtively
Overall Patient Satisfaction With Pain Control
Time frame: 48 hours post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 receiving 0.1 mg IT morphine and recieving 0.05 mg IT morphine in people with Cesarean Section, run by Medical University of South Carolina 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 3 inclusion and 16 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 19 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2024). 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?
Time to First Narcotic Rescue Dose in the First 24 Hours Post-cesarean Delivery. (time frame: 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 Dec 2024.