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I.H.1 I.H.1.1 I.H.1.2 I.H.1.3 I.H.1.4 I.H.1.5 I.H.1.6 I.H.1.7 I.H.1.8 I.H.1.9 I.H.2 I.H.2.1 I.H.2.2

Tolerance of Local Anesthetics . General Considerations . . . . . . . . . . Irritancy after Surface Anesthesia Irritancy after Intradermal Injection Irritancy after Subcutaneous Injection . . . . . . . . . . . . . . . . . . . . . . . . Irritancy after Intramuscular Injection . . . . . . . . . . . . . . . . . . . . . . . . Irritancy after Intraneural and Perineural Injection . . . . . . . . . . . . . . Irritancy after Epidural Anesthesia Irritancy after Intrathecal (Spinal) Injection . . . . . . . . . . . . . . . . . . . . . . . . Studies on Porphyrogenicity . . . . . Tolerance of Neuromuscular Blocking Agents . . . . . . . . . . . . . . . . General Considerations . . . . . . . . . . Evaluation of Autonomic Margins of Safety . . . . . . . . . . . . . . . . . . . . . . . .

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Schaumann O (1938) Chemie und Pharmakologie der Lokalanaesthetica. Naunyn-Schmiedeberg’s Arch exp Path Pharmakol 190:30–51

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I.H.1.2 Irritancy after Surface Anesthesia

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PURPOSE AND RATIONALE

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I.H.1 Tolerance of Local Anesthetics I.H.1.1 General Considerations One generally has to distinguish between surface anesthesia, infiltration anesthesia and conduction anesthesia (Fromherz 1922; Schaumann 1938; Camougis & Takman 1971). Special local tolerance tests have been developed for each of these applications including peridural and intrathecal injections. REFERENCES Camougis G, Takman BH (1971) Nerve and nerve-muscle preparations (as applied to local anesthetics) In: Schwartz A (ed) Methods in Pharmacology, Vol 1, Appleton-CenturyCrofts, Educational Division. Meredith Corp, New York, pp 1–40 Fromherz K (1922) Über die Wirkung verschiedener Gruppen der Lokalanästhetika im Lichte verschiedener Untersuchungsmethoden. Naunyn-Schmiedeberg’s Arch exp Path Pharmakol 93:72–91

Surface anesthesia is used to anesthetize the cornea and conjunctiva of the eye and the mucous membranes in the mouth. The classical pharmacological test is the blockade of the rabbit corneal reflex as described by Régnier (1923) that has become a standard test method for evaluating local anesthetics (Fußgänger and Schaumann 1931; Ther 1953a; Quevauviller 1971; Muschaweck et al. 1986). These pharmacological methods are only partially suitable to determine the irritancy potential of local anesthetic on mucus membranes. Luduena et al. (1960) compared the mucus membrane irritancy of mepivacaine and lidocaine by the eye irritation method according to Hoppe (1950) and Draize et al. (1944). For further description of the method see chapters I.N (Ocular Toxicity Tests) and I.P (Safety Assays in Skin Pharmacology). PROCEDURE

For the rabbit eye irritation tests, the rabbits are placed in ventilated boxes with only the head free. Solutions of local anesthetics in 0.9 % saline are prepared and a volume of 0.2 ml is instilled into the conjunctival sac of one eye, leaving the other as control. The lower lid is retracted gently and held away from

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