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Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

NCT03967288 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-06-21

No results posted yet for this study

Summary

The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. Clorotekal®, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..

Conditions

  • Anesthesia, Spinal

Interventions

DRUG

Chloroprocaine Injection [Clorotekal]

1% chloroprocaine Hydrochloride Injection (50 mg/5 mL) for intrathecal use

DRUG

Bupivacaine Hydrochloride 0.75% Injection Solution

0.75% bupivacaine Hydrochloride injection in 8.25% dextrose for intrathecal use

Sponsors & Collaborators

  • B. Braun Medical Inc.

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Brandon M Togioka, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03967288 on ClinicalTrials.gov