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The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.
When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.
The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air | Active Comparator | Air 3 ml used to identify epidural space |
|
| Saline | Active Comparator | Saline 3 ml used to identify epidural space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air | Procedure | 3 mls used for identifying epidural space |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Success of Spinal Labor Analgesia From Combined Spinal Epidural | Number of participants that had successful spinal labor analgesia in each group. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Failed Epidural Catheters | Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H. Pan, MSEE, 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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| ID | Title | Description |
|---|---|---|
| FG000 | 1-AIR | Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space |
| FG001 | 2-SALINE | Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-AIR | Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space |
| BG001 | 2-SALINE | Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space |
| 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 | Success of Spinal Labor Analgesia From Combined Spinal Epidural | Number of participants that had successful spinal labor analgesia in each group. | Posted | Count of Participants | Participants | 24 hours |
|
|
Adverse event data were collected from the time the epidural catheter was placed until the time of delivery, usually less than 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 | 1-AIR | Air 3 ml used to identify epidural space Air: 3 mls used for identifying epidural space |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Pan, MD | Wake Forest University School of Medicine | 336-718-82748 | ppan@wakehealth.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 | Oct 11, 2006 | Sep 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000388 | Air |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Procedure |
3 mls of saline used to identify epidural space |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Failed Epidural Catheters | Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 0 |
| 173 |
| 0 |
| 173 |
| 0 |
| 173 |
| EG001 | 2-SALINE | Saline 3 ml used to identify epidural space Saline: 3 mls of saline used to identify epidural space | 0 | 172 | 0 | 172 | 0 | 172 |
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| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |