Epidural Neostigmine for Labor Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00779467
First received: October 22, 2008
Last updated: June 4, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 Wake Forest School of Medicine:

Primary Outcome Measures:
  • Amount of drug consumed per hour in each group(Arm) [ Time Frame: after initial epidural dosing, every; 2 hours until delivery ] [ Designated as safety issue: Yes ]
    Drug amount consumed per hour of each group (arm) - To identify non-narcotic agents and the best dose to use in treating labor pain.


Enrollment: 157
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

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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00779467     History of Changes
Other Study ID Numbers: IRB5917
Study First Received: October 22, 2008
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
non narcotic
epidural
labor pain
Non narcotic treatment of labor pain

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

ClinicalTrials.gov processed this record on October 20, 2014