Epidural Neostigmine for Labor Pain

Wake Forest University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Labor Pain

Interventions

NeostigmineDRUG

utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.

BupivacaineDRUG

fentanylDRUG

fentanyl 2 mcg/ml

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Amount of Drug Consumed Per Hour in Each Group(Arm)

Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)

Time frame: until delivery

Secondary Outcomes

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

Time frame: until delivery

Sedation

average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy

Time frame: until delivery

Shivering

maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: within 24 hours post delivery

Data from ClinicalTrials.gov

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