Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

PHASE3TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2021

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.

Trial Locations (1)

3000

UZ Leuven, campus Gasthuisberg, Leuven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cross Research S.A.

INDUSTRY

lead

Sintetica SA

INDUSTRY