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The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine with Neostimgine 8 mcg/ml | Experimental | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML |
|
| Bupivacaine and Neostigmine 4 mcg/ml | Experimental | STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML |
|
| Bupivacaine with Neostigmine 2 mcg/ml | Experimental | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML |
|
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Active Comparator | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Drug Consumed Per Hour in Each Group(Arm) | Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm) | until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable | until delivery |
| Sedation | average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Pan, MD | Wake Forest University Health Sciences OB Anesthesia | 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 | Bupivacaine With Neostimgine 8 mcg/ml | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| FG001 | Bupivacaine and Neostigmine 4 mcg/ml | STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| FG002 | Bupivacaine With Neostigmine 2 mcg/ml | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| FG003 | BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine With Neostimgine 8 mcg/ml | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| BG001 | Bupivacaine and Neostigmine 4 mcg/ml |
| 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 | Amount of Drug Consumed Per Hour in Each Group(Arm) | Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm) | median hourly total bupivacaine consumption in each group, in ml/hr | Posted | Median | Inter-Quartile Range | milliliters per hour | until delivery |
|
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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 | Bupivacaine With Neostimgine 8 mcg/ml | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Pan, MD, MSEE | Wake Forest School of Medicine | 336-718-8278 | ppan@wakehealth.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 |
|---|---|
| D009388 | Neostigmine |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Bupivacaine | Drug |
|
| fentanyl | Drug | fentanyl 2 mcg/ml |
|
| until delivery |
| Shivering | maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably | until delivery |
| Pruritus | the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching. | until delivery |
| Bromage Score | the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block) | until delivery |
| Patient Satisfaction Scores | maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia | within 24 hours post delivery |
| Cesarean Delivery | percentage of subjects in each group requiring a ceserean delivery | occurence |
| failed inclusion criteria |
|
| missing data |
|
| technical issue |
|
| unavailable research staff |
|
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| BG002 | Bupivacaine With Neostigmine 2 mcg/ml | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| BG003 | BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Bupivacaine With Neostigmine 2 mcg/ml | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine |
| OG003 | BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml |
|
|
| Secondary | Nausea | average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable | Posted | Mean | Standard Deviation | units on a scale | until delivery |
|
|
|
| Secondary | Sedation | average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy | Posted | Mean | Standard Deviation | units on a scale | until delivery |
|
|
|
| Secondary | Shivering | maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably | Posted | Mean | Standard Deviation | units on a scale | until delivery |
|
|
|
| Secondary | Pruritus | the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching. | the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching. | Posted | Mean | Standard Deviation | units on a scale | until delivery |
|
|
|
| Secondary | Bromage Score | the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block) | Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block) | Posted | Mean | Standard Deviation | units on a scale | until delivery |
|
|
|
| Secondary | Patient Satisfaction Scores | maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia | Posted | Median | Inter-Quartile Range | units on a scale | within 24 hours post delivery |
|
|
|
| Secondary | Cesarean Delivery | percentage of subjects in each group requiring a ceserean delivery | Posted | Number | percentage of subjects in each group | occurence |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Bupivacaine and Neostigmine 4 mcg/ml | STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine | 0 | 40 | 0 | 40 |
| EG002 | Bupivacaine With Neostigmine 2 mcg/ml | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine | 0 | 38 | 0 | 38 |
| EG003 | BUPIVACAINE WITH FENTANYL 2 MCG/ML | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml | 0 | 35 | 0 | 35 |
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| D009861 |
| Onium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |