Epidural Neostigmine for Labor Pain
Epidural Neostigmine Dose Response for the Treatment of Labor Pain
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedSeptember 11, 2018
August 1, 2018
5.1 years
October 22, 2008
October 27, 2016
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of Drug Consumed Per Hour in Each Group(Arm)
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
until delivery
Secondary Outcomes (7)
Nausea
until delivery
Sedation
until delivery
Shivering
until delivery
Pruritus
until delivery
Bromage Score
until delivery
- +2 more secondary outcomes
Study Arms (4)
Bupivacaine with Neostimgine 8 mcg/ml
EXPERIMENTALSTUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Bupivacaine and Neostigmine 4 mcg/ml
EXPERIMENTALSTUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Bupivacaine with Neostigmine 2 mcg/ml
EXPERIMENTALSTUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
BUPIVACAINE WITH FENTANYL 2 MCG/ML
ACTIVE COMPARATORBupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Interventions
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Weight \> 115 kg
- Non-English speaking
- IV analgesics within 60 minutes prior to epidural being administered
- Allergy to local anesthetics or neostigmine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter H. Pan, MD, MSEE
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter H Pan, MD
Wake Forest University Health Sciences OB Anesthesia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 24, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
September 11, 2018
Results First Posted
April 10, 2017
Record last verified: 2018-08