Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorAretaieion University Hospital
About this trial
This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult parturients, American Society of Anesthesiologists (ASA) I-II,
singleton gestation>37 weeks
elective cesarean section
Disqualifiers
American Society of Anesthesiologists (ASA) > III
age < 18 years
singleton gestation <37 weeks
Body Mass Index (BMI) >40 kg/m2
Trial design
Design model
Parallel
Treatments tested in this trial
Chloroprocaine 1% Injectable Solution
Drug• in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally
Ropivacaine 0.75% Injectable Solution
Drug• in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: chloroprocaine groupActive comparator 1 intervention
Group B: ropivacaine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time from spinal anesthesia to T10 block (min)
time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome
Time frame
intraoperative2
Time from spinal anesthesia to T4 block (min)
time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome
Time frame
intraoperative3
Time of spinal anesthesia to Bromage =3
time required from spinal anesthetic injection to complete motor block (Bromage scale=3, where Bromage=0, no block; Bromage=1, partial block; Bromage=2, almost complete block; Bromage=3, complete block
Time frame
intraoperative4
level of sensory block every 3 min
measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes
Time frame
intraoperativeSecondary outcomes
1
Neonatal Apgar score at 1 minute
Neonatal Apgar score will be recorded at 1 minute after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts
Time frame
1 minute post delivery2
Neonatal Apgar score at 5 minutes
Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts
Time frame
1 minute post delivery3
neonatal blood gases
fetal cord blood analysis will be performed immediately post-delivery
Time frame
1 minute post delivery4
incidence of neonatal acidosis
incidence of neonatal acidosis (PH\<7.2) will be recorded
Time frame
1 minute post deliverySponsors and contacts
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Source ClinicalTrials.gov