Epidural Neostigmine for Labor Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epidural Neostigmine Dose Response for the Treatment of Labor Pain

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Bupivacaine
* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnancy Term pregnancy ( > 37 weeks) Primiparous or multiparous Induction or spontaneous labor greater or = 18 years of age Cervical exam on entry </=5 cm Exclusion Criteria: Weight > 115 kg Non-English speaking IV analgesics within 60 minutes prior to epidural being administered Allergy to local anesthetics or neostigmine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine with Neostimgine 8 mcg/ml<br>STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML | Drug: Neostigmine<br>* utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.<br>Drug: Bupivacaine<br> <br> |
| Experimental: Bupivacaine and Neostigmine 4 mcg/ml<br>STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML | Drug: Neostigmine<br>* utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.<br>Drug: Bupivacaine<br> <br> |
| Experimental: Bupivacaine with Neostigmine 2 mcg/ml<br>STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML | Drug: Neostigmine<br>* utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.<br>Drug: Bupivacaine<br> <br> |
| Active Comparator: BUPIVACAINE WITH FENTANYL 2 MCG/ML<br>Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION | Drug: Bupivacaine<br> <br> Drug: fentanyl<br>* fentanyl 2 mcg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non narcotic, epidural, labor pain, Non narcotic treatment of labor pain