Chloroprocaine

Overview

Chloroprocaine is an ester local anesthetic commonly available in its salt form, chloroprocaine hydrochloride. Similar to other local anesthetics, it increases the threshold for electrical excitation in nerves by slowing the propagation of the nerve impulse and reducing the rate of rise of the action potential. The pharmacological profile of chloroprocaine is characterized by a short latency and duration, similar to the one observed with lidocaine. Chloroprocaine can be given as an injection, and is available in formulations with and without methylparaben as a preservative. Both can be given as intrathecal injections for peripheral and central nerve block, but only the preservative-free formulation can be used for lumbar and caudal epidural blocks. Topical chloroprocaine for ophthalmic use was approved by the FDA in September 2022 for ocular surface anesthesia.

Indication

Chloroprocaine for intrathecal injection is indicated for the production of subarachnoid block (spinal anesthesia) in adults. It is also indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, and a preservative-free form can also be used for lumbar and caudal epidural blocks. Topical chloroprocaine for ophthalmic use is indicated for ocular surface anesthesia.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia	2024/06/25	NCT06472232	Phase 4	Not yet recruiting	Women's Hospital School Of Medicine Zhejiang University
Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section	2024/04/19	NCT06376058	Not Applicable	Recruiting	Aretaieion University Hospital
Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia.	2024/03/08	NCT06302257	Phase 4	Not yet recruiting	Hadassah Medical Organization
The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine	2023/07/06	NCT05934253	Phase 4	Recruiting	Harrow Inc
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population	2023/07/03	NCT05926258	Phase 3	Completed	Sintetica SA
Intrathecal Chloroprocaine for Lower Limb Arthroplasty	2022/05/09	NCT05365074	N/A	Completed	Hôpital de la Croix-Rousse
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.	2020/12/28	NCT04685538	Phase 3	Completed	Sintetica SA
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine	2020/04/30	NCT04369950	Phase 4	Completed	The University of Texas Health Science Center, Houston
Optimizing Anesthesia for Post Partum Tubal Ligations	2019/06/20	NCT03993314	Phase 2	Terminated	University of Alabama at Birmingham
Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery	2019/05/30	NCT03967288	Phase 4	Suspended	Oregon Health and Science University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nesacaine	Henry Schein, Inc.	0404-9926	INFILTRATION, PERINEURAL	10 mg in 1 mL	11/13/2023
(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1407	INFILTRATION, PERINEURAL	10 mg in 1 mL	1/29/2024
Clorotekal	B. Braun Medical Inc.	0264-7055	INTRATHECAL	10 mg in 1 mL	9/17/2018
NESACAINE	Henry Schein, Inc.	0404-9927	INFILTRATION, PERINEURAL	20 mg in 1 mL	11/13/2023
IHEEZO	Harrow Eye, LLC	82667-300	OPHTHALMIC	24 mg in 800 mg	2/21/2023
Nesacaine MPF	Fresenius Kabi USA, LLC	63323-477	INFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL	20 mg in 1 mL	9/1/2022
CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1408	INFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL	20 mg in 1 mL	1/28/2024
Nesacaine MPF	Fresenius Kabi USA, LLC	63323-478	INFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL	30 mg in 1 mL	9/1/2022
Chloroprocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	0143-9209	EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL	20 mg in 1 mL	2/25/2022
CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1401	INFILTRATION, PERINEURAL	20 mg in 1 mL	1/22/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NESACAINE CE 2% INJ 20MG/ML	astrazeneca canada inc	00613304	Solution - Epidural , Intracaudal	20 MG / ML	12/31/1984
NESACAINE CE 3% INJ 30MG/ML	astrazeneca canada inc	00613312	Solution - Epidural , Intracaudal	30 MG / ML	12/31/1984
CLOROTEKAL	B. Braun Melsungen AG	02551063	Solution - Intrathecal	10 MG / ML	3/4/2025

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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