Phase 1
Completed N=200
Epidural Neostigmine for Labor Pain
Source: ClinicalTrials.gov NCT00779467 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Amount of Drug Consumed Per Hour in Each Group(Arm) — 16.2; 14.6; 15.3; 16 milliliters per hour
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Drug Consumed Per Hour in Each Group(Arm) |
16.2; 14.6; 15.3; 16 | — |
| SECONDARY Nausea |
1.3; 1.8; 1.8; 1.2 | — |
| SECONDARY Sedation |
3.3; 3.4; 3.3; 4.1 | — |
| SECONDARY Shivering |
0.2; 0.3; 0.3; 0.2 | — |
| SECONDARY Pruritus |
0.05; 0.03; 0.03; 0.9 | — |
| SECONDARY Bromage Score |
0.7; 1.1; 1.0; 0.9 | — |
| SECONDARY Patient Satisfaction Scores |
4.5; 4.0; 4.0; 4.0 | — |
| SECONDARY Cesarean Delivery |
21; 15; 24; 14 | — |
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 115 kg
- Non-English speaking
- IV analgesics within 60 minutes prior to epidural being administered
- Allergy to local anesthetics or neostigmine
Data sourced from ClinicalTrials.gov (NCT00779467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.