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This study will investigate the dose of hydromorphone which will relieve the pain of women in labor 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 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement 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 and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. 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, fetal heart rate, and any side effects will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone | Experimental | Laboring patients 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 Score, Visual Analogue Pain Scores | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 30 minutes 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 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30290794 | Derived | O'Reilly-Shah V, Lynde GC. Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method. BMC Anesthesiol. 2018 Oct 5;18(1):140. doi: 10.1186/s12871-018-0603-8. |
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Subjects enrolled from January 2013 to November 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone | Laboring patients receive ED50 of hydromorphone one time intrathecally. ED50 of hydromorphone was 12.7 mcg +/- 3.27. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydromorphone | Laboring patients receive ED50 of hydromorphone one time intrathecally. ED50 of hydromorphone was 12.7 mcg +/- 3.27. |
| 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 Score, Visual Analogue Pain Scores | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Posted | Mean | Full Range | units on a scale | 30 minutes 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. ED50 of hydromorphone was 12.7 mcg +/- 3.27. |
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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 |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 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 |
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| 0 |
| 22 |
| 0 |
| 22 |
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| 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 |