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Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

NCT02862912 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-12-24

Study results available
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Summary

This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

Conditions

  • Adverse Reaction to Spinal Anesthetic
  • Maternal Care for Cervical Incompetence

Interventions

DRUG

Chloroprocaine

Administered as a single injection or continuously through an indwelling catheter - 50 mg

DRUG

Bupivacaine

A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)

DRUG

Fentanyl

15 mcg Fentanyl will be included int he spinal anesthetic in both groups

DRUG

Saline

Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml

Sponsors & Collaborators

Principal Investigators

  • Richard Smiley, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02862912 on ClinicalTrials.gov