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Epidural Neostigmine for Labor Pain

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ClinicalTrials.gov Identifier: NCT00779467
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : April 10, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Neostigmine Drug: Bupivacaine Drug: fentanyl Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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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
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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
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United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Peter H Pan, MD Wake Forest University Health Sciences OB Anesthesia
More Information
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00779467    
Other Study ID Numbers: IRB00005917
First Posted: October 24, 2008    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: September 11, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
non narcotic
epidural
labor pain
Non narcotic treatment of labor pain
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Fentanyl
Bupivacaine
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