---
title: Epidural Neostigmine for Labor Pain
nct_id: NCT00779467
overall_status: COMPLETED
phase: PHASE1
sponsor: Wake Forest University
study_type: INTERVENTIONAL
primary_condition: Labor Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00779467.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00779467"
ct_last_update_post_date: 2018-09-11
last_seen_at: "2026-05-12T07:19:10.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Epidural Neostigmine for Labor Pain

**Official Title:** Epidural Neostigmine Dose Response for the Treatment of Labor Pain

**NCT ID:** [NCT00779467](https://clinicaltrials.gov/study/NCT00779467)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Wake Forest University
- **Conditions:** Labor Pain
- **Start Date:** 2008-10
- **Completion Date:** 2013-11
- **CT.gov Last Update:** 2018-09-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Bupivacaine with Neostimgine 8 mcg/ml** (EXPERIMENTAL) — STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
- **Bupivacaine and Neostigmine 4 mcg/ml** (EXPERIMENTAL) — STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
- **Bupivacaine with Neostigmine 2 mcg/ml** (EXPERIMENTAL) — STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
- **BUPIVACAINE WITH FENTANYL 2 MCG/ML** (ACTIVE_COMPARATOR) — Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION

## Interventions

- **Neostigmine** (DRUG) — utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
- **Bupivacaine** (DRUG)
- **fentanyl** (DRUG) — fentanyl 2 mcg/ml

## Primary Outcomes

- **Amount of Drug Consumed Per Hour in Each Group(Arm)** _(time frame: until delivery)_ — Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)

## Secondary Outcomes

- **Nausea** _(time frame: until delivery)_
- **Sedation** _(time frame: until delivery)_
- **Shivering** _(time frame: until delivery)_
- **Pruritus** _(time frame: until delivery)_
- **Bromage Score** _(time frame: until delivery)_
- **Patient Satisfaction Scores** _(time frame: within 24 hours post delivery)_
- **Cesarean Delivery** _(time frame: occurence)_

## Locations (1)

- Forsyth Medical Center, Winston-Salem, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.forsyth medical center|winston-salem|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00779467.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00779467*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*