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Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

NCT02919072 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-21

Study results available
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Summary

The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.

Conditions

  • Unplanned Caesarean Section

Interventions

DRUG

Chloroprocaine

The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.

DRUG

Ropivacaine

The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Marc Van de Velde, MD · Department of Anesthesiology, UZ Leuven, campus Gasthuisberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Belgium

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 NCT02919072 on ClinicalTrials.gov