Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Condition(s) targeted: Anesthesia

Intervention: Chloroprocaine (Drug); Lidocaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Jinling Hospital, China

Official(s) and/or principal investigator(s):
Weiyan Li, M.D., Study Director, Affiliation: School of Medicine, Nanjing University

Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a short time, provides fast motor recovery and causes no significant side effects.

Official title: Low Epidural Anesthesia With Chloroprocaine Versus Lidocaine: a Prospective, Randomized, Double-blinded Multi-centre Clinical Trial in China

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Primary outcome: Epidural anesthesia effects of chloroprocaine versus lidocaine

Secondary outcome: Comparison of vital signs between chloroprocaine and lidocaine groups

Detailed description: Chloroprocaine hydrochloride is the chloridized local anesthetic of procaine hydrochloride, with twice the anesthetic intensity, four to five times the metabolization and half the side effect of procaine. The chloroprocaine hydrochloride product made in China has been on sale since 2002. To determine the clinical efficacy of low-epidural anesthesia with chloroprocaine versus lidocaine, the investigators carried out a prospective, randomized, double-blinded multi-centre clinical trial. The results demonstrate that epidural anesthesia using chloroprocaine has a more rapid onset time and shorter duration than with lidocaine. It can also provide a reliable sensory and motor block in epidural anesthesia, and is thus a more attractive alternative than lidocaine for middle and short duration surgical procedures.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Weight no more than 80 Kg or not more than 20% of normal weight

- American Society of Anesthesiologists (ASA) grade I or II

- No obstacles in thinking or language communication

- No epidural puncture contraindications such as disturbances of blood coagulation,

local infection of the puncture site or use of anticoagulants Exclusion Criteria:

- Chronic obstructive pulmonary diseases

- Serious heart, liver, renal and metabolic diseases

- Cerebral thrombosis and sequela

- Serious dehydration and electrolyte imbalance

- Neuromuscular diseases

- Pregnant or parturient women

- Abnormal liver and kidney function

Related publications:

FOLDES FF, McNALL PG. 2-Chloroprocaine: a new local anesthetic agent. Anesthesiology. 1952 May;13(3):287-96.

Steinemann TL, Sheikholeslami RR, Klein EF, Prokopius MJ. Short-acting peribulbar anesthesia with 2-chloroprocaine. J Cataract Refract Surg. 2002 Jan;28(1):195-6.

Hadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, Vloka JD, Rosenquist R, Santos AC, Thys DM. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004 Jul;101(1):127-32.

Liu SS, Ware PD, Rajendran S. Effects of concentration and volume of 2-chloroprocaine on epidural anesthesia in volunteers. Anesthesiology. 1997 Jun;86(6):1288-93; discussion 7A.

Sell A, Tein T, Pitkänen M. Spinal 2-chloroprocaine: effective dose for ambulatory surgery. Acta Anaesthesiol Scand. 2008 May;52(5):695-9. doi: 10.1111/j.1399-6576.2008.01639.x. Retraction in: Acta Anaesthesiol Scand. 2012 May;56(5):667.

Starting date: January 2008
Last updated: November 10, 2014