Intrathekales 1%iges 2-Chloroprocain im Vergleich zu 0,5%iges Bupivacain für ambulante Operationen. Eine prospektive, beobachterverblindete, randomisierte klinische Studie

Hintergrund: In der vorliegenden Arbeit werden zwei Lokalanästhetika in ihrer Wirksamkeit und ihrem Nebenwirkungsprofil im Hinblick auf kurzdauernde, ambulante Operationen in Spinalanästhesie miteinander verglichen: Bupivacain aus dem Bereich der niedrigdosierten, langwirksamen Lokalanästhetika, und...

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Bibliographic Details
Main Author: Leschka, Katharina
Contributors: Wulf, Hinnerk, (Prof. Dr. med.) (Thesis advisor)
Format: Doctoral Thesis
Language:German
Published: Philipps-Universität Marburg 2017
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Background: In the present study two local anesthetics are being compared concerning their efficacy and side effects regarding their use in ambulatory surgery in spinal anesthesia which are bupivacaine, being a low-dosed long-acting local anesthetic, and 2-Chloroprocaine, being a short-acting one. Since lidocaine is no longer used due to TNS an appropriate local anesthetic had been missing for short duration ambulatory surgery. This prospective, observer-blinded, randomized, multicenter study aimed at determining the non-inferiority of 50 mg of plain 1% 2-chloroprocaine vs. 10 mg of 0.5% plain bupivacaine in terms of sensory block onset time at T10 after spinal injection. The study hypothesis was that the difference in onset times of sensory block to T10 between the two drugs is ≤ 4 min. Methods: One hundred and thirty patients undergoing lower abdominal or lower limb procedures (≤ 40 min) were randomized to receive one of two treatments: 50 mg of plain 1% 2-chloroprocaine (n = 66) or 10 mg of plain 0.5% bupivacaine (n = 64). Times to sensory and motor block onsets, maximum sensory block level, readiness for surgery, regression of sensory and motor blocks, first analgesic requirements, unassisted ambulation, home discharge, and side effects after 24 h and 7 days were registered blindly. Results: 2-Chloroprocaine was comparable with plain 0.5% bupivacaine in terms of time to sensory block at T10 level. The group with 2-chloroprocaine showed faster onsets of motor block (5 vs. 6 min), maximum sensory block level (8.5 vs. 14 min), resolution of sensory (105 vs. 225 min) and motor (100 vs. 210 min) blocks, unassisted ambulation (142.5 vs. 290.5 min), first analgesic requirement (120 vs. 293.5 min), and home discharge (150 vs. 325 min) (all comparisons, P < 0.05). No chloroprocaine patient developed transient neurological symptoms. Conclusion: Spinal anesthesia with 50 mg of plain 1% 2-chloroprocaine is similar to 10 mg of plain 0.5% bupivacaine in terms of onset of sensory block at T10 but shows quicker recovery from anesthesia than with 0.5% bupivacaine. 2-Chloroprocaine represents a local anesthetic that shows a well-suited profile especially for short duration ambulatory surgery. This is also confirmed by the official approval of 2-chloroprocaine for spinal anesthesia for surgeries with a duration <40minutes in March 2013 in Europe.