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Slow recruitment of subjects
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The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.
The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Morphine | Active Comparator | Group receiving 3mg epidural morphine, 24 hours after the initial dose |
|
| Epidural Saline | Placebo Comparator | Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Morphine | Drug | Patients will be given 3mg epidural morphine, 24 hours after the initial dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery | The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups. | Up to 48 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Lee, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8213024 | Background | Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x. | |
| 10735794 | Background | Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Morphine | Group receiving 3mg epidural morphine, 24 hours after the initial dose Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose. |
| FG001 | Epidural Saline | Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Morphine | Group receiving 3mg epidural morphine, 24 hours after the initial dose Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose. |
| BG001 | Epidural Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery | The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups. | Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero ("0") for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank. | Posted | Up to 48 hours post-operatively |
|
Up to 48 hours post-surgery
Women undergoing cesarean section under epidural anesthesia virtually always receive epidural morphine for post-operative analgesia. The 5 women did not experience any unexpected/reportable serious or non-serious adverse effects from the epidural morphine after cesarean section.
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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 | Epidural Morphine | Group receiving 3mg epidural morphine, 24 hours after the initial dose Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison Lee | Columbia University | 305-582-6077 | al3196@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Epidural Saline | Drug | Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. |
|
|
Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Epidural Saline | Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. |
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Epidural Saline | Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg. | 0 | 5 | 0 | 5 |
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| D017670 |
| Sodium Compounds |