Early Phase 1
N=70
Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery
Surgical Anesthesia, Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT03414359 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: The Onset Time to Surgical Anesthesia — 558; 655 seconds — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- 2% Lidocaine (Drug); 3% Chloroprocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Onset Time to Surgical Anesthesia |
558; 655 | 0.10 |
| SECONDARY Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation |
4; 7 | — |
Summary
Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age for the mother
- Singleton pregnancy
- Gestation > 36 weeks
- American Society of Anesthesiologist (ASA) class II
- Provides written consent
- Infant of mother
Exclusion Criteria
- Patient refusal
- Non-elective or urgent/emergent cesarean sections
- ASA class III or above
- Unable to understand English
- Significant back surgery or scoliosis
- Known fetal abnormality
- Weight > 120 kg
- Height < 150 cm
- Allergy to local anesthetics
- Concurrent use of sulfonamides
Data sourced from ClinicalTrials.gov (NCT03414359). 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.