Clinical Trial: Epidural Neostigmine for Labor Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Wake Forest University

Current Primary Outcome: Amount of Drug Consumed Per Hour in Each Group(Arm) [ Time Frame: until delivery ]

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


Original Primary Outcome: To identify non-narcotic agents and the best dose to use in treating labor pain. [ Time Frame: Throughout labor analgesia ]

Current Secondary Outcome:

  • Nausea [ Time Frame: until delivery ]
    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
  • Sedation [ Time Frame: until delivery ]
    average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
  • Shivering [ Time Frame: until delivery ]
    maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
  • Pruritus [ Time Frame: until delivery ]
    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.
  • Bromage Score [ Time Frame: until delivery ]
    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)
  • Patient Satisfaction Scores [ Time Frame: within 24 hours post delivery ]
    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
  • Cesarean Delivery [ Time Frame: occurence ]
    percentage of subjects in each group requiring a ceserean delivery


Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: October 22, 2008
Date Started: October 2008
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017