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Multicenter Study Controlled Clinical Trial
Influence of height on ED95 of intrathecal 2-chloroprocaine for knee arthroscopy: A prospective dose-response clinical trial.
- Emmanuel Guntz, Gaelle Jeanne, Jonathan Gouwy, Mehdi M'rini, Sarah Saxena, Jean-François Fils, and Yota Kapessidou.
- From the Department of Anaesthesia, Hôpital de Braine l'Alleud Waterloo, 35 rue Wayez, 1420 Braine l'Alleud-Waterloo, Université Libre de Bruxelles (ULB), Belgium (EG, JGa, JGo), Department of Anaesthesia, University Hospital Saint Pierre, Bruxelles, ULB, Belgium (MM, YK), Department of Anaesthesia, CHU de Charleroi, Charleroi, ULB, Belgium (SS) and Ars Statistica Private Statistic Society (S.P.R.L). Nivelles (J-FF).
- Eur J Anaesthesiol. 2022 Jul 1; 39 (7): 602-610.
BackgroundPlain 2-chloroprocaine , a rapid acting amino-ester-type local anaesthetic, is used in short ambulatory procedures under spinal anaesthesia. The ED 95 of 2-chloroprocaine for lower limb surgery has not yet been defined. Moreover, patients' body height could influence the effects of the administered dose.ObjectivesThe aim of this study was to determine the ED 95 of plain 2-chloroprocaine based on the height of patients undergoing ambulatory knee arthroscopy under spinal anaesthesia using the continual reassessment statistical method (CRM).DesignProspective, dose-response, double blind, controlled, bi-center, clinical trial.SettingOne university teaching hospital in Brussels and one general teaching hospital, Braine l'Alleud, Belgium. Université libre de Bruxelles.PatientsASA I-III (120 patients) scheduled for day-case knee arthroscopy under spinal anaesthesia.InterventionsPatients were divided into three groups of 40, each comprising 10 cohorts of 4 patients, according to their respective heights (Group 1: 150-165 cm, Group 2: 166-180 cm, Group 3: 181-195 cm). Each patient enrolled into one of the 3 groups received an intrathecal dose of plain 2-chloroprocaine determined by the CRM. The starting doses for the first cohorts of four were 40 mg in group 1, 45 mg in group 2 and 50 mg in group 3. The doses for subsequent cohorts were determined by CRM of outcomes in all patients in the previous competed cohorts. Anaesthesia was considered successful when there was a lack of pinprick or cold sensation up to T12, the visual analogue scale score for tourniquet pain was < 2 and no pain during surgery.Main OutcomesThe primary outcome was the success or failure of the block. Side effects were also recorded.ResultsED 95 of 2-chloroprocaine is 40 mg in group 1, 35 mg in group 2, 45 mg in group 3. Groups were different in terms of height and gender ( P < 0.05) and similar in terms of body mass index and age ( P > 0.05).ConclusionThe ED95 of intrathecal 2-chloroprocaine for patients undergoing ambulatory knee arthroscopy is between 35 and 45 mg. Height could be a factor involved in the calculation, and patient sex could partly explain the nonlinear relation between height and dose.Trial Registry NumberClinicaltrials.gov NCT03882489.Copyright © 2022 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.
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