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feasibility of population needed to complete study
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The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.
Subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. The subjects may or may not also receive acetaminophen orally postoperatively. Pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| duramorph | Active Comparator | duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours |
|
| no duramorph | Experimental | no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duramorph | Drug | duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Itching | The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Booth, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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Recruitment and enrollment occurred between December 2011 and September 2013. The study was terminated due to extreme difficulty in recruiting patients willing to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duramorph | duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| FG001 | no Duramorph | no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duramorph | duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| 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 | Pain | Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
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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 | Duramorph | duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
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Early termination leading to small number of subjects analyzed. Extreme difficulty in recruiting participants to participate in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Booth | Wake Forest School of Medicine | 3367188278 | jbooth@wakehealth.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| placebo | Drug | placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
|
| Nausea/Vomiting | The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting. | 24 hours |
| BG001 |
| no Duramorph |
no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| gravida | number of times a woman has been pregnant | Mean | Full Range | number |
|
| para | number of births a woman has had after 20 weeks of gestation | Mean | Full Range | number |
|
| estimated gestational age of fetus | Mean | Full Range | weeks |
|
| height | Mean | Full Range | inches |
|
| weight | Mean | Full Range | pounds |
|
no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. |
|
|
| Secondary | Itching | The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Secondary | Nausea/Vomiting | The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | no Duramorph | no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. | 0 | 6 | 0 | 6 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |