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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| receiving 0.1 mg IT morphine | Active Comparator | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine |
|
| recieving 0.05 mg IT morphine | Experimental | Patients will receive 0.05 mg of intrathecal morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| receiving 0.1 mg IT morphine | Drug | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Ambulation After C-section | This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated. | up to 48 hours |
| Opioid Medication Given During the Participant's Hospital Stay. |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria consist of any parturient 18 years of age or older who is undergoing elective cesarean delivery under spinal anesthesia and is able to consent to the study and participate in the follow-up.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Receiving 0.1 mg IT Morphine | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine |
| FG001 | Recieving 0.05 mg IT Morphine | Patients will receive 0.05 mg of intrathecal morphine recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receiving 0.1 mg IT Morphine | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine |
| BG001 | Recieving 0.05 mg IT Morphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | hours | 24 hours |
|
Adverse event data was collected from randomization through 48-hours postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Receiving 0.1 mg IT Morphine | Patients will receive the standard of care dose 0.1 mg of intrathecal morphine receiving 0.1 mg IT morphine: Patients will receive the standard of care dose 0.1 mg of intrathecal morphine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Op Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Hatter, M.D. | Medical University of South Carolina | (843) 792-5454 | herbertk@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2023 | Jul 8, 2024 | Prot_SAP_000.pdf |
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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.
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Patients will be blinded
| recieving 0.05 mg IT morphine | Drug | Patients will receive 0.05 mg of intrathecal morphine |
|
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.
| 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. | 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. | 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 | 48 hours post-op |
Patients will receive 0.05 mg of intrathecal morphine recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Prior C-Section, yes | Count of Participants | Participants |
|
|
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| Secondary | Time to First Ambulation After C-section | This outcome evaluated the amount of time reported in hours after c-section the patient first ambulated. | Posted | Median | Inter-Quartile Range | hours | up to 48 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | From the time of the procedure through discharge, up to 48 hours. |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 24-hours post operatively and 48-hours post operatively |
|
|
|
| Secondary | 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. | Posted | Number | participants | 24 hours post operavtively |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 48 hours post-op |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 68 |
| 101 |
| EG001 | Recieving 0.05 mg IT Morphine | Patients will receive 0.05 mg of intrathecal morphine recieving 0.05 mg IT morphine: Patients will receive 0.05 mg of intrathecal morphine | 0 | 100 | 0 | 100 | 62 | 100 |
| Post-Op Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Post-op vomiting, yes |
|
| Pruritis, yes |
|