Trial Outcomes & Findings for Epidural Neostigmine for Labor Pain (NCT NCT00779467)

NCT ID: NCT00779467

Last Updated: 2018-09-11

Results Overview

Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 200 participants
• Primary outcome timeframe: until delivery
• Results posted on: 2018-09-11

Participant Flow

Participant milestones

Measure	Bupivacaine With Neostimgine 8 mcg/ml STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Overall Study STARTED	53	45	48	54
Overall Study COMPLETED	38	40	38	35
Overall Study NOT COMPLETED	15	5	10	19

Reasons for withdrawal

Measure	Bupivacaine With Neostimgine 8 mcg/ml STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Overall Study Lack of Efficacy	11	2	6	11
Overall Study failed inclusion criteria	3	3	1	2
Overall Study missing data	1	0	1	4
Overall Study technical issue	0	0	2	1
Overall Study unavailable research staff	0	0	0	1

Baseline Characteristics

Epidural Neostigmine for Labor Pain

Baseline characteristics by cohort

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml	Total n=151 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 5 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=7 Participants	28 years STANDARD_DEVIATION 6 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=4 Participants	27.5 years STANDARD_DEVIATION 5.75 • n=21 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	40 Participants n=7 Participants	38 Participants n=5 Participants	35 Participants n=4 Participants	151 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: until delivery

Population: median hourly total bupivacaine consumption in each group, in ml/hr

Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Amount of Drug Consumed Per Hour in Each Group(Arm)	16.2 milliliters per hour Interval 12.0 to 23.0	14.6 milliliters per hour Interval 12.0 to 18.0	15.3 milliliters per hour Interval 13.0 to 19.0	16 milliliters per hour Interval 13.0 to 21.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Nausea	1.3 units on a scale Standard Deviation 2.5	1.8 units on a scale Standard Deviation 3.0	1.8 units on a scale Standard Deviation 3.0	1.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: until delivery

average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Sedation	3.3 units on a scale Standard Deviation 3.0	3.4 units on a scale Standard Deviation 3.0	3.3 units on a scale Standard Deviation 2.9	4.1 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: until delivery

maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Shivering	0.2 units on a scale Standard Deviation 0.4	0.3 units on a scale Standard Deviation 0.4	0.3 units on a scale Standard Deviation 0.5	0.2 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: until delivery

Population: the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.

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.

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Pruritus	0.05 units on a scale Standard Deviation 0.3	0.03 units on a scale Standard Deviation 0.2	0.03 units on a scale Standard Deviation 0.2	0.9 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: until delivery

Population: 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)

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)

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Bromage Score	0.7 units on a scale Standard Deviation 0.7	1.1 units on a scale Standard Deviation 1.4	1.0 units on a scale Standard Deviation 0.9	0.9 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Patient Satisfaction Scores	4.5 units on a scale Interval 3.0 to 5.0	4.0 units on a scale Interval 4.0 to 5.0	4.0 units on a scale Interval 3.0 to 5.0	4.0 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: occurence

percentage of subjects in each group requiring a ceserean delivery

Outcome measures

Measure	Bupivacaine With Neostimgine 8 mcg/ml n=38 Participants STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine and Neostigmine 4 mcg/ml n=40 Participants STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	Bupivacaine With Neostigmine 2 mcg/ml n=38 Participants STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. Bupivacaine	BUPIVACAINE WITH FENTANYL 2 MCG/ML n=35 Participants Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Bupivacaine fentanyl: fentanyl 2 mcg/ml
Cesarean Delivery	21 percentage of subjects in each group	15 percentage of subjects in each group	24 percentage of subjects in each group	14 percentage of subjects in each group

Adverse Events

Bupivacaine With Neostimgine 8 mcg/ml

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine and Neostigmine 4 mcg/ml

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine With Neostigmine 2 mcg/ml

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BUPIVACAINE WITH FENTANYL 2 MCG/ML

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter H. Pan, MD, MSEE

Wake Forest School of Medicine

Phone: 336-718-8278

Email: ppan@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place