It's Time for Clorotekal®

CLOROTEKAL (chloroprocaine hydrochloride injection) is indicated for:

• the induction of spinal anaesthesia by intrathecal administration, in adults undergoing surgical procedures no longer than 40 minutes in duration.

CLOROTEKAL is contraindicated:

• in patients who are hypersensitive to this drug, medicinal products of the PABA (para-ami-nobenzoic acid) ester group, or to any ingredient in the formulation, including any non-me-dicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• in patients with general and specific contraindications to spinal anaesthesia regardless of the local anaesthetic used, should be taken into account (e.g. decompensated cardiac in-sufficiency, hypovolemic shock).
• for intravenous regional anaesthesia (IVRA).
• in patients with serious problems with cardiac conduction.
• in patients with severe anaemia.
• in patients taking anticoagulants or those with congenital or acquired bleeding disorder.
• in patients with septicemia or local infection at the site of the proposed lumbar puncture.

Study Design:

• Study 1 was a phase 2 single-center, prospective, randomized, observer-blinded study.
• Evaluated the efficacy and the tolerability of 1% chloroprocaine in three doses 30, 40, and 50 mg after spinal injection.
• In 45 adult patients undergoing short duration (<40 minutes) lower limb surgery.

Efficacy Results:

• Neither rescue anesthesia nor rescue analgesia was required for subjects randomized to chloroprocaine 50 mg.
• Three subjects in the 30 mg dose group and three subjects in the 40 mg dose group required intraoperative rescue medications.
• Doses above 50 mg have not been adequately tested for efficacy and safety.

^{*Spinal anesthesia with Chloroprocaine HCl 1% for elective lower limb procedures of short duration: a prospective, randomized, observer-blinded study in adult patients.}

Study Design:

• Study 2 was a phase 3, multicenter, prospective, randomized, observer-blinded study.
• Evaluated the safety and efficacy of 50 mg of chloroprocaine 10 mg/mL in intrathecal anesthesia versus 10 mg of bupivacaine 0.5%.
• In 130 adult patients undergoing short duration (<40 minutes) low abdominal surgery (gynecological or urological) and lower limb surgery.
• Each patient received a single dose of anesthetic: 50 mg of chloroprocaine or 10 mg of bupivacaine.

Efficacy Results:

• Efficacy was determined by the proportion of patients who were able to complete the surgical procedure without the need for rescue intravenous analgesic or sedation drugs.
• Efficacy results proved that 6 of 66 subjects (9%) in the chloroprocaine group required rescue compared to 6 of 64 (9%) in the bupivacaine group.

^{*Prospective, observer-blinded, randomized clinical study to investigate and compare the efficacy of intrathecal plain solutions containing Chloroprocaine 1% (50 mg) versus Bupivacaine 0.5% (10mg)}