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This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.
After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone | Experimental | Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 12 hours after intrathecal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Baseline |
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant C Lynde, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
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Subjects enrolled from January 2013 to June 2014 at Grady Memorial Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone | Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydromorphone | Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg. |
| 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 | Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | 12 hours after intrathecal injection |
|
|
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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 | Hydromorphone | Laboring patients receive ED50 of hydromorphone one time intrathecally Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief. ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grant Lynde | Emory University | 404-778-3900 | glynde@emory.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 |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 6 hours after intrathecal injection |
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 18 hours after intrathecal injection |
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 24 hours after intrathecal injection |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | Baseline |
|
|
|
| Secondary | Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | 6 hours after intrathecal injection |
|
|
|
| Secondary | Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | 18 hours after intrathecal injection |
|
|
|
| Secondary | Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | 24 hours after intrathecal injection |
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| 0 |
| 20 |
| 0 |
| 20 |
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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 |