Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 17, 2013

Primary Completion Date

August 21, 2015

Study Completion Date

October 18, 2017

Conditions
Pain Relief During Labour
Interventions
DRUG

Spinal administration of chloroprocaine.

"In order to determine the minimum effective dose that is to be given spinally, an up-down sequential allocation will be used.~Efficacy of the analgesia will be evaluated by a 100mm visual analogue pain score (VAPS). There are two possible outcomes here:~* effective: the VAPS is 10mm or lower after the 15 minutes of monitoring. An effective result will decrease the test dose of chloroprocaine with 2mg for the next patient in this study.~* Ineffective: the VAPS is more than 10mm after 15 minutes of monitoring. An ineffective result will increase the test dose of chloroprocaine with 2mg for the next patient in this study. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 12ml levobupivacaine epidurally."

Trial Locations (1)

9000

Ghent University Hospital, Ghent

All Listed Sponsors
lead

University Hospital, Ghent

OTHER

NCT01909089 - Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour | Biotech Hunter | Biotech Hunter