Early Phase 1
Completed N=15
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
Source: ClinicalTrials.gov NCT03760718 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Chloroprocaine Plasma Concentration at 1 Minute — 14.3; 7.5; 3.5 ng/ml
Summary
The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chloroprocaine Plasma Concentration at 1 Minute |
14.3; 7.5; 3.5 | — |
| PRIMARY Chloroprocaine Plasma Concentration at 5 Minutes |
14.5; 14.1; 323.1 | — |
| PRIMARY Chloroprocaine Plasma Concentration at 10 Minutes |
10.4; 6.0; 217.9 | — |
| PRIMARY Chloroprocaine Plasma Concentration at 20 Minutes |
2.2; 1.7; 3.4 | — |
| PRIMARY Chloroprocaine Plasma Concentration at 30 Minutes |
3.4; 1.2; 3.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health & Science University (OHSU).
- Only subjects having spinal anesthesia will be eligible.
- Only subjects that can have a Pfannenstiel incision will be enrolled.
Exclusion Criteria
- Subjects with chronic narcotic usage
- Subjects that are deemed to need a combined spinal epidural for any reason.
- Subjects who are unable to successfully get a spinal block
- Subjects with known atypical cholinesterase activity
- American Society of Anesthesiologist physical status IV or higher
- Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)
- Subjects with stage 4 chronic kidney disease or worse (eGFR 2x the upper limit of normal)
- Subjects with allergies to drugs required for this protocol.
- Subjects with multifetal gestations
- Subjects with a BMI > 40 kg/m2
Data sourced from ClinicalTrials.gov (NCT03760718). 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.