A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections

Description:

This study is designed as a randomised prospective double blind multi centre study.

Following approval by the Hospital Ethics committee of the University Hospital Antwerp and
all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned
for a caesarean section will be asked to participate in this trial.

Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal
bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer
are not aware of the local anaesthetic solution administered.

Preoperative a combined spinal epidural puncture will be performed in the sitting position at
the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block
characteristics ( onset, duration and intensity of the sensory block and motor block) will be
measured at regular intervals.

Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the
epidural catheter.

Time of birth, neonatal outcome (Apgar score 1 min, 5 min and 10 minutes after birth) and
admission to the nicu as well as umbilicus venous and arterial blood gasses are recorded.

Patients will be discharged from the PACU when motor block reached a Bromage score 1 Time
intervals of discharge to the ward will be registered.At the maternity ward the time of first
contact of the baby and the mother and first breast feed (if applicable) will be registered.

One week postoperative patients will be called and asked if they experienced any
postoperative symptoms like headache, micturition problems or symptoms resembling Transient
Neurological Symptoms

Condition:

Combined Spinal Epidural Anesthesia

Treatment:

combined spinal epidural anaesthesia

Start Date:

August 1, 2017

Sponsor:

University Hospital, Antwerp

For More Information:

https://clinicaltrials.gov/show/NCT03219086