Clinical trial NCT06376058: Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
Official title: Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section
Local Anesthetic
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* adult parturients, American Society of Anesthesiologists (ASA) I-II,
* singleton gestation\>37 weeks
* elective cesarean section

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time from spinal anesthesia to T10 block (min)
timeFrame: intraoperative
measure: Time from spinal anesthesia to T4 block (min)
timeFrame: intraoperative
measure: Time of spinal anesthesia to Bromage =3
timeFrame: intraoperative
measure: level of sensory block every 3 min
timeFrame: intraoperative
measure: level of sensory block every 15 min
timeFrame: intraoperative
measure: highest level of sensory block
timeFrame: intraoperative
measure: time from spinal anesthesia to highest level of sensory block
timeFrame: intraoperative
measure: duration of sensory block
timeFrame: intraoperative
measure: pain at surgical incision
timeFrame: intraoperative
measure: pain at neonatal delivery
timeFrame: intraoperative
measure: pain at peritoneal manipulation
timeFrame: intraoperative
measure: pain at Post Anesthesia Care Unit (PACU) admission
timeFrame: 1 hour postoperatively
measure: pain at Post Anesthesia Care Unit (PACU) discharge
timeFrame: 1 hour postoperatively
measure: need for rescue analgesia intraoperatively
timeFrame: intraoperative
measure: Bromage scale every 3 min after spinal anesthesia
timeFrame: intraoperative
measure: Bromage scale every 15 min
timeFrame: intraoperative
measure: duration of motor block
timeFrame: 1 hour postoperatively
measure: duration of staying in PACU
timeFrame: 2 hours postoperatively
Secondary outcomes:
measure: Neonatal Apgar score at 1 minute
timeFrame: 1 minute post delivery
measure: Neonatal Apgar score at 5 minutes
timeFrame: 1 minute post delivery
measure: neonatal blood gases
timeFrame: 1 minute post delivery
measure: incidence of neonatal acidosis
timeFrame: 1 minute post delivery
measure: incidence of hypotension
timeFrame: intraoperative
measure: incidence of bradycardia
timeFrame: intraoperative
measure: need for vasoconstrictor
timeFrame: intraoperative
measure: need for atropine
timeFrame: intraoperative
measure: incidence of nausea/vomiting
timeFrame: intraoperative
measure: incidence of dizziness
timeFrame: intraoperative
measure: incidence of drowsiness
timeFrame: intraoperative
measure: incidence of discomfort
timeFrame: intraoperative
measure: incidence of shivering
timeFrame: intraoperative
measure: need for rescue analgesia in PACU
timeFrame: 2 hours postoperatively
measure: time from spinal anesthesia to rescue analgesia in PACU
timeFrame: 2 hours postoperatively
measure: incidence of neurological symptoms during hospital stay
timeFrame: 5 days postoperatively
measure: incidence of neurological symptoms 2 months after the operation
timeFrame: 2 months after discharge
measure: incidence of low back pain
timeFrame: 2 months after discharge
measure: time from spinal anesthesia to mobilization
timeFrame: 2 days postoperatively
measure: mother's satisfaction from anesthesia
timeFrame: 1 day postoperatively
measure: gynecologist's satisfaction
timeFrame: 1 hour postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maes S, Laubach M, Poelaert J. Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section. Acta Anaesthesiol Scand. 2016 May;60(5):642-9. doi: 10.1111/aas.12665. Epub 2015 Nov 26.
citation: Saporito A, Ceppi M, Perren A, La Regina D, Cafarotti S, Borgeat A, Aguirre J, Van De Velde M, Teunkens A. Does spinal chloroprocaine pharmacokinetic profile actually translate into a clinical advantage in terms of clinical outcomes when compared to low-dose spinal bupivacaine? A systematic review and meta-analysis. J Clin Anesth. 2019 Feb;52:99-104. doi: 10.1016/j.jclinane.2018.09.003. Epub 2018 Sep 18.
citation: Singariya G, Choudhary K, Kamal M, Bihani P, Pahuja H, Saini P. Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study. Indian J Anaesth. 2021 Feb;65(2):102-107. doi: 10.4103/ija.IJA_816_20. Epub 2021 Feb 10.
citation: Baribeault T, Suss S. Spinal Anesthesia with 2-Chloroprocaine and Dexmedetomidine for Cesarean Section: A Case Report. AANA J. 2023 Jun;91(3):194-196.