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An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 mls saline injected | Placebo Comparator | NO SALINE INJECTED |
|
| 15 mls saline | Active Comparator | 15ML SALINE ADMINISTERED EPIDURALLY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile normal saline 0 mls | Other | at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor. |
| Measure | Description | Time Frame |
|---|---|---|
| Highest Sensory Blockade Level to Pinprick and to Cold | Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1) | up to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia (Time to Request Additional Analgesia) | time of CSE to time request of additional supplement analgesia in minutes | up 120 minutes |
| Onset of Analgesia | time to VAS\ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Pan, MD, MSEE | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center-Sara Lee Center for Women's Health | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0 Mls Saline Injected | NO SALINE INJECTED Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor. |
| FG001 | 15 Mls Saline | 15ML SALINE ADMINISTERED EPIDURALLY 15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0 Mls Saline Injected | NO SALINE INJECTED Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor. |
| 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 | Highest Sensory Blockade Level to Pinprick and to Cold | Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1) | Posted | Mean | Standard Deviation | units on a scale | up to 20 minutes |
|
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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 | 0 Mls Saline Injected | NO SALINE INJECTED Sterile normal saline 0 mls: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Pan, MD | Wake Forest University School of Medicine | 336-718-8278 | 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 | Jan 25, 2011 | Sep 5, 2018 | Prot_SAP_000.pdf |
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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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|
| 15 mls sterile normal saline | Other | After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications. |
|
| up to 20 minutes |
| Time to Highest Sensory Block | up to 20 minutes |
| Number of Participants Who Had Occurrence of Fetal Bradycardia | occurrence of common side effects of spinal/epidural administration | length of labor, up to 24 hours |
| Number of Participants Who Had Occurrence of Maternal Hypotension | length of labor, up to 24 hours |
| Occurrence of Use of Vasopressors | length of labor, up to 24 hours |
| Number of Participants Who Had Occurrence of Itching | length of labor, up to 24 hours |
| Number of Participants Who Had Occurrence of Post Dural Puncture Headache | length of labor, up to 24 hours |
| Time for 2 Dermatome Level Regression of Sensory Block | up to 20 minutes |
| Time for Regression of Motor Blockade | up to 20 minutes |
| BG001 |
| 15 Mls Saline |
15ML SALINE ADMINISTERED EPIDURALLY 15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
15ML SALINE ADMINISTERED EPIDURALLY
15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.
|
|
| Secondary | Duration of Analgesia (Time to Request Additional Analgesia) | time of CSE to time request of additional supplement analgesia in minutes | Posted | Mean | Standard Deviation | minutes | up 120 minutes |
|
|
|
| Secondary | Onset of Analgesia | time to VAS\ | Posted | Mean | Standard Deviation | minutes | up to 20 minutes |
|
|
|
| Secondary | Time to Highest Sensory Block | Posted | Mean | Standard Deviation | minutes | up to 20 minutes |
|
|
|
| Secondary | Number of Participants Who Had Occurrence of Fetal Bradycardia | occurrence of common side effects of spinal/epidural administration | Posted | Count of Participants | Participants | length of labor, up to 24 hours |
|
|
|
| Secondary | Number of Participants Who Had Occurrence of Maternal Hypotension | Posted | Count of Participants | Participants | length of labor, up to 24 hours |
|
|
|
| Secondary | Occurrence of Use of Vasopressors | Posted | Count of Participants | Participants | length of labor, up to 24 hours |
|
|
|
| Secondary | Number of Participants Who Had Occurrence of Itching | Posted | Count of Participants | Participants | length of labor, up to 24 hours |
|
|
|
| Secondary | Number of Participants Who Had Occurrence of Post Dural Puncture Headache | Posted | Count of Participants | Participants | length of labor, up to 24 hours |
|
|
|
| Secondary | Time for 2 Dermatome Level Regression of Sensory Block | No data collected | Posted | up to 20 minutes |
|
|
| Secondary | Time for Regression of Motor Blockade | No data collected | Posted | up to 20 minutes |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 15 Mls Saline | 15ML SALINE ADMINISTERED EPIDURALLY 15 mls sterile normal saline: After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications. | 0 | 28 | 0 | 28 | 0 | 28 |
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