Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
- Conditions
- Cesarean SectionLocal Anesthetic
- Interventions
- Registration Number
- NCT06376058
- Lead Sponsor
- Aretaieion University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- adult parturients, American Society of Anesthesiologists (ASA) I-II,
- singleton gestation>37 weeks
- elective cesarean section
- American Society of Anesthesiologists (ASA) > III
- age < 18 years
- singleton gestation <37 weeks
- Body Mass Index (BMI) >40 kg/m2
- Body weight <50 kg
- Body weight>100 kg
- height<150 cm
- height>180 cm
- multiple gestation
- emergency delivery
- fetal abnormality
- fetal distress
- pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities
- pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases
- lack of informed consent
- contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ropivacaine group Ropivacaine 0.75% Injectable Solution intrathecal fixed dose of ropivacaine 0.75% chloroprocaine group Chloroprocaine 1% Injectable Solution intrathecal fixed dose of chloroprocaine 1%
- Primary Outcome Measures
Name Time Method duration of staying in PACU 2 hours postoperatively duration of parturient stay in PACU
level of sensory block every 15 min intraoperative measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery
pain at neonatal delivery intraoperative pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
pain at peritoneal manipulation intraoperative pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
pain at Post Anesthesia Care Unit (PACU) discharge 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 from spinal anesthesia to T10 block (min) intraoperative time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome
Time from spinal anesthesia to T4 block (min) intraoperative time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome
Time of spinal anesthesia to Bromage =3 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
level of sensory block every 3 min intraoperative measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes
highest level of sensory block intraoperative measurement of the highest level of sensory block after intrathecal infusion of local anesthetic
time from spinal anesthesia to highest level of sensory block intraoperative time from the performance of spinal anesthesia to the highest level of sensory block
duration of sensory block intraoperative measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2
pain at surgical incision intraoperative pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable
pain at Post Anesthesia Care Unit (PACU) admission 1 hour postoperatively pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
need for rescue analgesia intraoperatively intraoperative need for rescue analgesia during the operation, via epidural catheter or intravenously
Bromage scale every 3 min after spinal anesthesia intraoperative measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes
Bromage scale every 15 min intraoperative measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery
duration of motor block 1 hour postoperatively measurement of time required for bromage scale to regress from 3 to 0
- Secondary Outcome Measures
Name Time Method need for atropine intraoperative any need for atropine during the operation because of bradycardia will be recorded
incidence of drowsiness intraoperative any occurence of drowsiness during the operation will be recorded
incidence of discomfort intraoperative any occurence of discomfort during the operation will be recorded
neonatal blood gases 1 minute post delivery fetal cord blood analysis will be performed immediately post-delivery
need for vasoconstrictor intraoperative any need for vasoconstrictor during the operation will be recorded
time from spinal anesthesia to rescue analgesia in PACU 2 hours postoperatively time from spinal anesthesia to rescue analgesia in PACU will be recorded
Neonatal Apgar score at 5 minutes 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
Neonatal Apgar score at 1 minute 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
incidence of neonatal acidosis 1 minute post delivery incidence of neonatal acidosis (PH\<7.2) will be recorded
incidence of hypotension intraoperative any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
incidence of bradycardia intraoperative any incidence of maternal bradycardia (heart rate\<60/min) will be recorded
incidence of dizziness intraoperative any occurence of dizziness during the operation will be recorded
incidence of nausea/vomiting intraoperative any occurence of nausea and/or vomiting during the operation will be recorded
incidence of shivering intraoperative any occurence of shivering during the operation will be recorded
need for rescue analgesia in PACU 2 hours postoperatively need for rescue analgesia in PACU when VAS scale \>4 will be recorded
incidence of neurological symptoms during hospital stay 5 days postoperatively incidence of neurological symptoms during hospitalization will be recorded
incidence of low back pain 2 months after discharge incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication
time from spinal anesthesia to mobilization 2 days postoperatively time from spinal anesthesia to mobilization of parturient will be recorded
mother's satisfaction from anesthesia 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
gynecologist's satisfaction 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
incidence of neurological symptoms 2 months after the operation 2 months after discharge incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication
Trial Locations
- Locations (1)
Aretaieion University Hospital
🇬🇷Athens, Greece