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Completed

NCT Number: NCT00779467

Epidural Neostigmine for Labor Pain

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine

Drug

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

Bupivacaine

Drug

Fentanyl

Drug

fentanyl 2 mcg/ml

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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)

  6. 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

  7. Cesarean Delivery

    Time frame: occurence

    percentage of subjects in each group requiring a ceserean delivery

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

Epidural Neostigmine Dose Response for the Treatment of Labor Pain

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2008
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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