Aretaieion University Hospital
Athens, 11528, Greece
Location status: Recruiting
Location contact
Kassiani Theodoraki, PhD, DESA
CONTACT
Marianna Mavromati, MD
CONTACT
NCT Number: NCT06376058
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
Interested in participating?
Request Info18 year–48 year
Female
Interventional
Not applicable
Athens, 11528, Greece
Location status: Recruiting
Kassiani Theodoraki, PhD, DESA
CONTACT
Marianna Mavromati, MD
CONTACT
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided. Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections. Various local anesthetics have been used, but ropivacaine is the drug of choice in most hospitals in Greece. However, chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action. Chloroprocaine was initially used in 1980, but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate (EDTA) in the early formulations. Nowadays, new formulations of the drug without EDTA makes chloroprocaine safe for use.
The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: intraoperative
time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome
Time frame: intraoperative
time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome
Time frame: intraoperative
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: intraoperative
measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes
Time frame: intraoperative
measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery
Time frame: intraoperative
measurement of the highest level of sensory block after intrathecal infusion of local anesthetic
Time frame: intraoperative
time from the performance of spinal anesthesia to the highest level of sensory block
Time frame: intraoperative
measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2
Time frame: intraoperative
pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable
Time frame: intraoperative
pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
Time frame: intraoperative
pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
Time frame: 1 hour postoperatively
pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
Time frame: 1 hour postoperatively
pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
Time frame: intraoperative
need for rescue analgesia during the operation, via epidural catheter or intravenously
Time frame: intraoperative
measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes
Time frame: intraoperative
measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery
Time frame: 1 hour postoperatively
measurement of time required for bromage scale to regress from 3 to 0
Time frame: 2 hours postoperatively
duration of parturient stay in PACU
Time frame: 1 minute post delivery
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 delivery
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 delivery
fetal cord blood analysis will be performed immediately post-delivery
Time frame: 1 minute post delivery
incidence of neonatal acidosis (PH<7.2) will be recorded
Time frame: intraoperative
any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded
Time frame: intraoperative
any incidence of maternal bradycardia (heart rate<60/min) will be recorded
Time frame: intraoperative
any need for vasoconstrictor during the operation will be recorded
Time frame: intraoperative
any need for atropine during the operation because of bradycardia will be recorded
Time frame: intraoperative
any occurence of nausea and/or vomiting during the operation will be recorded
Time frame: intraoperative
any occurence of dizziness during the operation will be recorded
Time frame: intraoperative
any occurence of drowsiness during the operation will be recorded
Time frame: intraoperative
any occurence of discomfort during the operation will be recorded
Time frame: intraoperative
any occurence of shivering during the operation will be recorded
Time frame: 2 hours postoperatively
need for rescue analgesia in PACU when VAS scale >4 will be recorded
Time frame: 2 hours postoperatively
time from spinal anesthesia to rescue analgesia in PACU will be recorded
Time frame: 5 days postoperatively
incidence of neurological symptoms during hospitalization will be recorded
Time frame: 2 months after discharge
incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication
Time frame: 2 months after discharge
incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication
Time frame: 2 days postoperatively
time from spinal anesthesia to mobilization of parturient will be recorded
Time frame: 1 day postoperatively
mother's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction
Time frame: 1 hour postoperatively
gynecologist's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction
Contact information is provided by the study sponsor or research team.
Kassiani Theodoraki, PhD, DESA
CONTACT
Marianna Mavromati, MD
CONTACT
Aretaieion University Hospital
Other
Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study
Acronym: annie-mariana
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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