Epidural Neostigmine for Labor Pain

Phase 1

Completed

• Conditions: Labor Pain
• Interventions: Drug: Neostigmine; Drug: Bupivacaine; Drug: fentanyl

• Registration Number: NCT00779467
• Lead Sponsor: Wake Forest University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-24
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2016-10-27
• Results First Submitted QC: 2017-02-23
• Results First Posted: 2017-04-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine and Neostigmine 4 mcg/ml	Bupivacaine	STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Bupivacaine with Neostimgine 8 mcg/ml	Neostigmine	STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
Bupivacaine with Neostimgine 8 mcg/ml	Bupivacaine	STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
BUPIVACAINE WITH FENTANYL 2 MCG/ML	fentanyl	Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine with Neostigmine 2 mcg/ml	Bupivacaine	STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
BUPIVACAINE WITH FENTANYL 2 MCG/ML	Bupivacaine	Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Bupivacaine and Neostigmine 4 mcg/ml	Neostigmine	STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
Bupivacaine with Neostigmine 2 mcg/ml	Neostigmine	STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML

Primary Outcome Measures

Name	Time	Method
Amount of Drug Consumed Per Hour in Each Group(Arm)	until delivery	Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)

Secondary Outcome Measures

Name	Time	Method
Shivering	until delivery	maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
Patient Satisfaction Scores	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
Bromage Score	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)
Nausea	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
Cesarean Delivery	occurence	percentage of subjects in each group requiring a ceserean delivery
Sedation	until delivery	average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
Pruritus	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.

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States