Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287870
• Other study ID #: 2007NLY-004
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2014
• Last updated: November 10, 2014
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: November 2014
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Chloroprocaine
60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.
• Lidocaine
60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

References & Publications (10)

Bjørnestad E, Iversen OL, Raeder J. Similar onset time of 2-chloroprocaine and lidocaine + epinephrine for epidural anesthesia for elective Cesarean section. Acta Anaesthesiol Scand. 2006 Mar;50(3):358-63. — View Citation

Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 200 — View Citation

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

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. — View Citation

Jafari S, Kalstein AI, Nasrullah HM, Hedayatnia M, Yarmush JM, SchianodiCola J. A randomized, prospective, double-blind trial comparing 3% chloroprocaine followed by 0.5% bupivacaine to 2% lidocaine followed by 0.5% bupivacaine for interscalene brachial p — View Citation

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. — View Citation

Marica LS, O'Day T, Janosky JE, Nystrom EU. Chloroprocaine is less painful than lidocaine for skin infiltration anesthesia. Anesth Analg. 2002 Feb;94(2):351-4, table of contents. — View Citation

Marsch SC, Sluga M, Studer W, Barandun J, Scharplatz D, Ummenhofer W. 0.5% versus 1.0% 2-chloroprocaine for intravenous regional anesthesia: a prospective, randomized, double-blind trial. Anesth Analg. 2004 Jun;98(6):1789-93, table of contents. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural anesthesia effects of chloroprocaine versus lidocaine	The effects of epidural anesthesia are assessed by onset time of epidural block, pain free and recovery time, the upper block level and time, the degree of muscle relaxation, and motor recovery time.	Four months (January - April, 2008)
Secondary	Comparison of vital signs between chloroprocaine and lidocaine groups	The vital signs are assessed by diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse oxygen saturation (SpO2).	Four months (January - April, 2008)