Epidural Neostigmine for Labor Pain

Labor Pain Clinical Trial

Official title:

Epidural Neostigmine Dose Response for the Treatment of Labor Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779467
• Other study ID #: IRB00005917
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Est. completion date: November 2013

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
• Bupivacaine

• fentanyl
fentanyl 2 mcg/ml

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	until delivery
Secondary	Sedation	average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy	until delivery
Secondary	Shivering	maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably	until delivery
Secondary	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.	until delivery
Secondary	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)	until delivery
Secondary	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	within 24 hours post delivery
Secondary	Cesarean Delivery	percentage of subjects in each group requiring a ceserean delivery	occurence