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Chloroprocaine During Caesarean Section S ORIGINAL ARTICLE Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section S. Maes1, M. Laubach2 and J. Poelaert1 1Department of Anaesthesiology and Perioperative Medicine, UZ Brussel, Brussels, Belgium 2Department of Gynaecology, UZ Brussel, Brussels, Belgium Correspondence Background: Neuraxial anaesthesia is the desired method for S. Maes, UZ Brussel, Laarbeeklaan 101, 1090 Caesarean section. Bupivacaine is a well-known local anaesthetic. Jette, Belgium It has a long duration of action and can cause unpredictable levels E-mail: [email protected] of anaesthesia with subsequent prolonged discharge time. Conflicts of interest 2-Chloroprocaine has a rapid onset of action, producing an excel- The authors have nothing to disclose. lent sensory and motor block and has a rapid hydrolysis in the bloodstream by pseudocholinesterase. We compared bupivacaine Funding and 2-chloroprocaine for spinal anaesthesia during Caesarean sec- Departmental funding only was used to tion. The primary endpoint was the earliest reversal sign of the perform this study. motor block. Methods: Sixty ASAI/II patients, planned for elective singleton Submitted 31 May 2015; accepted 3 November 2015; submission 24 December Caesarean section, were equally randomised to three groups. All 2014. patients received a combined spinal–epidural anaesthesia. The first group received 2-chloroprocaine (40 mg) without sufentanil, Citation the second group received 2-chloroprocaine (40 mg) with sufen- Maes S, Laubach M, Poelaert J. Randomised tanil (1 lg) and the third group received hyperbaric bupivacaine controlled trial of spinal anaesthesia with (7.5 mg) with sufentanil (1 lg) as a spinal anaesthetic. Motor and bupivacaine or 2-chloroprocaine during sensory blockade were assessed at specific time points. caesarean section. Acta Anaesthesiologica Scandinavica 2016 Results: There was no difference between the three groups regarding the time to regression of the motor block. However, at doi: 10.1111/aas.12665 5 min post spinal injection, the level of sensory block was higher for both groups with 2-chloroprocaine, in comparison with the bupivacaine group. Conclusion: 2-Chloroprocaine can be used for low risk Cae- sarean section in healthy parturients. There is no difference in time to motor block resolution compared to bupivacaine. Motor recovery seems more predictable for 2-chloroprocaine and may be beneficial for the breastfeeding initiation. Editorial comment: what this article tells us This study tells us that while spinal anaesthesia with 2-chloroprocaine for low-risk Caesarean sec- tion has a fast onset for sensory block, it also has a predictable and relatively rapid motor block recovery time. Neuraxial anaesthesia in combination with to general anaesthesia and has reportedly low spinal–epidural anaesthesia (CSE) is the gold maternal mortality.1,2 In addition, parturients standard method for Caesarean section (CS). It remain awake during surgery thus experiencing is safe to the parturient and newborn compared the birth of their baby. The spinal component Acta Anaesthesiologica Scandinavica 60 (2016) 642–649 642 ª 2015 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd CHLOROPROCAINE SPINAL ANAESTHESIA provides rapid onset of anaesthesia while the We tested the null hypothesis in a prospective epidural catheter allows administration of local single blinded manner that the earliest regres- anaesthetics during and after surgery to main- sion of the motor block between the three tain analgesia.3 groups was not different. Also, the effectiveness Bupivacaine is a well-known amide-type local and characteristics of sensory blockade, the dif- anaesthetic, which has been used as a spinal ferences regarding maternal blood pressure and anaesthetic since the 1960s. It has a long dura- heart rate, neonatal effects and side effects have tion of action and can cause unpredictable levels been assessed. of anaesthesia, which are dose dependent with – subsequent prolonged discharge time.4 6 Even Methods with small doses of bupivacaine, disadvantages have been reported. These include inadequate After Ethical Committee approval (Ethical Com- blockade height for the surgical procedure, uri- mittee Clinical Trials, University Hospital Brus- nary retention, prolonged block resolution, sels 2013/186) and approval by the Belgian which leads to delayed discharge from the post- Federal Agency for Medicines and Health Prod- anaesthesia care unit (PACU).4 Our current hos- ucts (FAMHP – 582184), we conducted a pital policy states that parturients should remain prospective controlled trial. (EudraCT 2013- in PACU until complete reversal of the motor 002815-88) block. During this time the newborn remains on the maternal ward. This has implications and Patients potential delays with the first breastfeeding ses- sion.7 Despite drawbacks, bupivacaine remains After signed informed consent, all in-term widely in use for CS.8,9 patients (≥ 37 weeks) with American Society of Chloroprocaine (2-chloroprocaine, 2-CP) is an Anaesthesiologists (ASA) physical status I or II, ester-type local anaesthetic that was introduced planned for a CS were consecutively included to into clinical practice in 1952 and used success- participate to this blinded randomised trial. fully in 214 patients as a spinal anaesthetic.10 Included were all women with an uncompli- 2-CP has a rapid onset of action, producing an cated, singleton pregnancy. Patients were aged excellent sensory and motor block and has a between 18 and 40 years. Exclusion criteria rapid hydrolysis in the bloodstream by pseudo- included ASA physical status III and IV, urgent cholinesterase. These characteristics account for and emergent CS, twin and multiple pregnancy, its early popularity, particularly in obstetrics. gestational age less than 37 weeks, body mass 2-CP has a short plasma half-life minimising index (weight/height2) (BMI) > 35 kg/m2 possible systemic toxicity for the mother and (before pregnancy), maternal height < 150 cm, foetus. Concerns in the 1980s regarding the foetus with known or suggested congenital mal- safety and potential neurotoxicity of 2-CP were formations, known allergy for the used local highlighted by several reports of high dose anaesthetics and (pre)eclampsia. intrathecal administration of 2-CP.11,12 These complications were associated with the acidic Study protocol solution and in particular the preservative bisulfite.13 Since 1996, 2-CP was manufactured The recommendations by the Consolidated Stan- without additives and the pH of the solution dards of Reporting Trials (CONSORT) for improved. Multiple studies with healthy reporting a randomised, controlled clinical trial volunteers showed good results without com- were followed. All patients were equally ran- plications. They found a predictable time of domised in three groups. Numbered sealed onset, blockade height and time to complete envelopes, from 1 (first patient) to 60 (last regression.6,14,15 patient), following a computer-generated list, Recently, 2-CP has been marketed solely for were used to reveal group allocation just before spinal use. Contemporary evidence on the cur- the procedure. Each envelope contained a card rent form of 2-CP is limited in relation to spinal showing the relevant group. The anaesthetist, anaesthesia for CS. who also was the assessor, opened the envelope Acta Anaesthesiologica Scandinavica 60 (2016) 642–649 ª 2015 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd 643 S. MAES ET AL. just before starting the procedure. The first flexion, 5 = weak dorsiflexion of feet, 6 = weak group received 2-CP (40 mg) without sufentanil plantar flexion of feet. Sensory block was (group C), the second group received 2-CP assessed by loss of cold sensation. The currently (40 mg) with sufentanil (1 lg) (group C+S) and recommended level of sensory block for CS is the third group received hyperbaric bupivacaine T5–T4.17 (9 mg) with sufentanil (1 lg) (group B+S). Sin- Pain was assessed at 5, 10, 20, 30, 40, 50 and gle blinding was achieved by not revealing 60 min after injection, by using a VAS (Visual group allocation to the patients. Analogue Scale). Maternal blood pressure, heart rate, oxygen saturation, presence of nausea and vomiting were recorded at the same time points Monitoring as pain was assessed. Maternal hypotension Before initiation of spinal block, the following was registered and defined as a drop of systolic parameters were measured and recorded: mater- blood pressure of more than 20% of the baseline nal age, length, weight before pregnancy, value that was measured before initiation of the weight at the end of pregnancy, medical history procedure. In this case, a bolus of 100 lg and pregnancy term. Furthermore, maternal phenylephrine was given till blood pressure blood pressure, heart rate and oxygen saturation returned within 20% of starting value limits. were noted before initiation of anaesthesia and Time of birth, neonatal outcome (Apgar score) were referred as baseline values. All patients and admission to NICU were recorded as well received a fluid loading of 500 ml colloid solu- as umbilical venous and arterial blood gasses. â tion (Volulyte ) with 200 lg phenylephrine, End of surgery time was recorded and motor/ 30 min before the start of the procedure16, sensory block were tested again in those which is standard care in our institution. patients who did not receive a top up dose The CSE technique is summarised: the epidu-
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