Epidural Neostigmine for Labor Pain

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Labor Pain

Treatments: Drug: fentanyl; Drug: Neostigmine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00779467

IRB00005917

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

Bupivacaine with Neostimgine 8 mcg/ml

Experimental group

Description:

STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML

Treatment:

Drug: Bupivacaine

Drug: Neostigmine

Bupivacaine and Neostigmine 4 mcg/ml

Experimental group

Description:

STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML

Treatment:

Drug: Bupivacaine

Drug: Neostigmine

Bupivacaine with Neostigmine 2 mcg/ml

Experimental group

Description:

STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML

Treatment:

Drug: Bupivacaine

Drug: Neostigmine

BUPIVACAINE WITH FENTANYL 2 MCG/ML

Active Comparator group

Description:

Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION

Treatment:

Drug: Bupivacaine

Drug: fentanyl