Epidural Neostigmine for Labor Pain
Primary Purpose
Labor Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neostigmine
Bupivacaine
fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring non narcotic, epidural, labor pain, Non narcotic treatment of labor pain
Eligibility 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
Sites / Locations
- Forsyth Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Bupivacaine with Neostimgine 8 mcg/ml
Bupivacaine and Neostigmine 4 mcg/ml
Bupivacaine with Neostigmine 2 mcg/ml
BUPIVACAINE WITH FENTANYL 2 MCG/ML
Arm Description
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Outcomes
Primary Outcome Measures
Amount of Drug Consumed Per Hour in Each Group(Arm)
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
Secondary Outcome Measures
Nausea
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
average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
Shivering
maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
Pruritus
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
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
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
percentage of subjects in each group requiring a ceserean delivery
Full Information
NCT ID
NCT00779467
First Posted
October 22, 2008
Last Updated
August 13, 2018
Sponsor
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT00779467
Brief Title
Epidural Neostigmine for Labor Pain
Official Title
Epidural Neostigmine Dose Response for the Treatment of Labor Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
non narcotic, epidural, labor pain, Non narcotic treatment of labor pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine with Neostimgine 8 mcg/ml
Arm Type
Experimental
Arm Description
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Arm Title
Bupivacaine and Neostigmine 4 mcg/ml
Arm Type
Experimental
Arm Description
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Arm Title
Bupivacaine with Neostigmine 2 mcg/ml
Arm Type
Experimental
Arm Description
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
Arm Title
BUPIVACAINE WITH FENTANYL 2 MCG/ML
Arm Type
Active Comparator
Arm Description
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
fentanyl 2 mcg/ml
Primary Outcome Measure Information:
Title
Amount of Drug Consumed Per Hour in Each Group(Arm)
Description
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
Time Frame
until delivery
Secondary Outcome Measure Information:
Title
Nausea
Description
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
Time Frame
until delivery
Title
Sedation
Description
average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
Time Frame
until delivery
Title
Shivering
Description
maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
Time Frame
until delivery
Title
Pruritus
Description
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.
Time Frame
until delivery
Title
Bromage Score
Description
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)
Time Frame
until delivery
Title
Patient Satisfaction Scores
Description
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
Time Frame
within 24 hours post delivery
Title
Cesarean Delivery
Description
percentage of subjects in each group requiring a ceserean delivery
Time Frame
occurence
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Pan, MD
Organizational Affiliation
Wake Forest University Health Sciences OB Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Epidural Neostigmine for Labor Pain
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