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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloroprocaine group | Active Comparator | intrathecal fixed dose of chloroprocaine 1% |
|
| ropivacaine group | Active Comparator | intrathecal fixed dose of ropivacaine 0.75% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine 1% Injectable Solution | Drug | • in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from spinal anesthesia to T10 block (min) | time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome | intraoperative |
| Time from spinal anesthesia to T4 block (min) | time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome | intraoperative |
| 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 | intraoperative |
| level of sensory block every 3 min | measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes | intraoperative |
| level of sensory block every 15 min | measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery | intraoperative |
| highest level of sensory block | measurement of the highest level of sensory block after intrathecal infusion of local anesthetic | intraoperative |
| time from spinal anesthesia to highest level of sensory block | time from the performance of spinal anesthesia to the highest level of sensory block |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Contact | 6974634162 | ktheodoraki@hotmail.com | |
| Marianna Mavromati, MD | Contact | marimavr14@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Aretaieion University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieion University Hospital | Recruiting | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26608876 | Background | 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. | |
| 30237085 | Background | 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. |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine 0.75% Injectable Solution | Drug | • in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally |
|
| intraoperative |
| duration of sensory block | measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2 | intraoperative |
| pain at surgical incision | pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable | intraoperative |
| pain at neonatal delivery | pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable | intraoperative |
| pain at peritoneal manipulation | pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable | intraoperative |
| pain at Post Anesthesia Care Unit (PACU) admission | pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable | 1 hour postoperatively |
| pain at Post Anesthesia Care Unit (PACU) discharge | pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable | 1 hour postoperatively |
| need for rescue analgesia intraoperatively | need for rescue analgesia during the operation, via epidural catheter or intravenously | intraoperative |
| Bromage scale every 3 min after spinal anesthesia | measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes | intraoperative |
| Bromage scale every 15 min | measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery | intraoperative |
| duration of motor block | measurement of time required for bromage scale to regress from 3 to 0 | 1 hour postoperatively |
| duration of staying in PACU | duration of parturient stay in PACU | 2 hours postoperatively |
| 1 minute post delivery |
| 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 | 1 minute post delivery |
| neonatal blood gases | fetal cord blood analysis will be performed immediately post-delivery | 1 minute post delivery |
| incidence of neonatal acidosis | incidence of neonatal acidosis (PH<7.2) will be recorded | 1 minute post delivery |
| incidence of hypotension | any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded | intraoperative |
| incidence of bradycardia | any incidence of maternal bradycardia (heart rate<60/min) will be recorded | intraoperative |
| need for vasoconstrictor | any need for vasoconstrictor during the operation will be recorded | intraoperative |
| need for atropine | any need for atropine during the operation because of bradycardia will be recorded | intraoperative |
| incidence of nausea/vomiting | any occurence of nausea and/or vomiting during the operation will be recorded | intraoperative |
| incidence of dizziness | any occurence of dizziness during the operation will be recorded | intraoperative |
| incidence of drowsiness | any occurence of drowsiness during the operation will be recorded | intraoperative |
| incidence of discomfort | any occurence of discomfort during the operation will be recorded | intraoperative |
| incidence of shivering | any occurence of shivering during the operation will be recorded | intraoperative |
| need for rescue analgesia in PACU | need for rescue analgesia in PACU when VAS scale >4 will be recorded | 2 hours postoperatively |
| time from spinal anesthesia to rescue analgesia in PACU | time from spinal anesthesia to rescue analgesia in PACU will be recorded | 2 hours postoperatively |
| incidence of neurological symptoms during hospital stay | incidence of neurological symptoms during hospitalization will be recorded | 5 days postoperatively |
| incidence of neurological symptoms 2 months after the operation | incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication | 2 months after discharge |
| incidence of low back pain | incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication | 2 months after discharge |
| time from spinal anesthesia to mobilization | time from spinal anesthesia to mobilization of parturient will be recorded | 2 days postoperatively |
| mother's satisfaction from anesthesia | 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 | 1 day postoperatively |
| gynecologist's satisfaction | 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 | 1 hour postoperatively |
| 33776083 | Background | 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. |
| 37227957 | Background | 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. |
| D000588 |
| Amines |