Epidural Neostigmine for Labor Pain - Full Text View

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00779467

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

Drug Information available for: Neostigmine Methylsulfate Neostigmine Bupivacaine hydrochloride Bupivacaine Neostigmine bromide Fentanyl Fentanyl Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Epidural Neostigmine Dose Response for the Treatment of Labor Pain

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

To identify non-narcotic agents and the best dose to use in treating labor pain. [ Time Frame: after initial epidural dosing, every; 2 hours until delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bupivacaine with Neostimgine 8 mcg/ml: Experimental	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
Bupivacaine and Neostigmine 4 mcg/ml: Experimental	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
Bupivacaine with Neostigmine 2 mcg/ml: Experimental	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
1: Active Comparator Bupivacaine with fentanyl 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 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

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779467

Contacts

Contact: Lynne Harris, BSN

336-716-9957

lcharris@wfubmc.edu

Locations

United States, North Carolina
Forsyth Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Lynne Harris, BSN 336-716-9957
Principal Investigator: Peter H Pan, MD
Sub-Investigator: James Eisenach, MD
Sub-Investigator: Robert D'Angelo, MD
Sub-Investigator: Ashley Tonidandel, MD
Sub-Investigator: Vernon Ross, MD
Sub-Investigator: John Thomas, MD
Sub-Investigator: Newell Daly, MD
Sub-Investigator: Brian Paitsel, MD
Sub-Investigator: Nichole Taylor, MD
Sub-Investigator: David Hood, MD
Sub-Investigator: Terrence Bogard, MD
Sub-Investigator: Medge Owen, MD
Sub-Investigator: Kenneth Nelson, MD

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Peter H Pan, MD

Wake Forest University Health Sciences OB Anesthesia

More Information

No publications provided

Responsible Party:	Wake Forest University Heatlh Sciences-OB Anesthesia ( Peter H. Pan, MD )
Study ID Numbers:	IRB5917
Study First Received:	October 22, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00779467 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest University:

non narcotic
epidural
labor pain
Non narcotic treatment of labor pain

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Fentanyl
Neostigmine
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants
Pain
Narcotics
Cholinergic Agents

Anesthetics, Local
Cholinesterase Inhibitors
Signs and Symptoms
Anesthetics, General
Labor Pain
Neurologic Manifestations
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Parasympathomimetics
Neurotransmitter Agents
Fentanyl
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Pain
Cholinergic Agents
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Analgesics
Analgesics, Opioid
Anesthetics, Intravenous
Neostigmine

Nervous System Diseases
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Anesthetics, Local
Adjuvants, Anesthesia
Cholinesterase Inhibitors
Autonomic Agents
Anesthetics, General
Labor Pain
Neurologic Manifestations
Bupivacaine
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009