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Epidural Neostigmine for Labor Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779467
First Posted: October 24, 2008
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Labor Pain Drug: Neostigmine Drug: Bupivacaine Drug: fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidural Neostigmine Dose Response for the Treatment of Labor Pain

Resource links provided by NLM:


Further study details as provided by Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: October 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine with Neostimgine 8 mcg/ml
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
Experimental: Bupivacaine and Neostigmine 4 mcg/ml
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
Experimental: Bupivacaine with Neostigmine 2 mcg/ml
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
Active Comparator: BUPIVACAINE WITH FENTANYL 2 MCG/ML
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Drug: Bupivacaine Drug: fentanyl
fentanyl 2 mcg/ml

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779467


Locations
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Peter H Pan, MD Wake Forest University Health Sciences OB Anesthesia
  More Information

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00779467     History of Changes
Other Study ID Numbers: IRB5917
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: October 27, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017

Keywords provided by Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences:
non narcotic
epidural
labor pain
Non narcotic treatment of labor pain

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Neostigmine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents