Phase 4
Completed N=47
ED90 of 3% Chloroprocaine for Cervical Cerclage
Cerclage, Cervical
Source: ClinicalTrials.gov NCT03805438 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required). — 49.5 mg
◆ Published Evidence
Established
▲ Trending
20citations · ~5 / year
ED 90 of Intrathecal Chloroprocaine With Fentanyl for Prophylactic Cervical Cerclage: A Sequential Allocation Biased-Coin Design.
Summary
The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that provides effective anesthesia in 90% of patients undergoing elective cerclage placement (intraoperative analgesic supplementation not required).
Linked Publications
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ED 90 of Intrathecal Chloroprocaine With Fentanyl for Prophylactic Cervical Cerclage: A Sequential Allocation Biased-Coin Design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required). |
49.5 | — |
| SECONDARY Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU). |
— | — |
| SECONDARY Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no). |
8 | — |
| SECONDARY Number of Participants With Observed Vomiting. (Observed Yes or no). |
1 | — |
| SECONDARY Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no). |
2 | — |
| SECONDARY Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic. |
13 | — |
| SECONDARY The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic. |
320 | — |
| SECONDARY Overall Patient Satisfaction at Time of PACU Discharge. |
10 | — |
| SECONDARY Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU). |
60 | — |
| SECONDARY Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes |
150 | — |
| SECONDARY Time From Spinal Block to Ambulation |
60 | — |
| SECONDARY Time From Spinal Block to Micturition |
150 | — |
| SECONDARY Time to Complete Sensory Regression |
90 | — |
| SECONDARY Time to Resolution of Motor Block (Bromage Score of 5) |
60 | — |
| SECONDARY Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria) |
150 | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Singleton pregnancy
- ASA class II or III
- Cervical cerclage 1st or 2nd trimester of pregnancy
- Simple prophylactic cervical cerclage
Exclusion Criteria
- Patient refusal
- Abdominal and complex cervical cerclage (e.g. bulging bag)
- BMI ≥ 50 kg/m2
- ASA class IV or above
- Contraindication to neuraxial anesthesia
- Allergy to chloroprocaine
Data sourced from ClinicalTrials.gov (NCT03805438) and the linked publication. 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.