Clinical trial NCT02287870: Epidural Anesthesia With Chloroprocaine Versus Lidocaine
Official title: Low Epidural Anesthesia With Chloroprocaine Versus Lidocaine: a Prospective, Randomized, Double-blinded Multi-centre Clinical Trial in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Epidural anesthesia
Chloroprocaine
Lidocaine
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Epidural anesthesia effects of chloroprocaine versus lidocaine
timeFrame: Four months (January - April, 2008)
Secondary outcomes:
measure: Comparison of vital signs between chloroprocaine and lidocaine groups
timeFrame: Four months (January - April, 2008)
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine, Nanjing University
name: Weiyan Li, M.D.
role: STUDY_DIRECTOR
References:
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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. doi: 10.1016/s0886-3350(01)00899-9.
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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. doi: 10.1097/00000542-199706000-00009.
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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):1789-1793. doi: 10.1213/01.ANE.0000116929.45557.CE.
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 plexus block. Anesth Analg. 2008 Nov;107(5):1746-50. doi: 10.1213/ane.0b013e318185cd5e.
citation: Bjornestad 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. doi: 10.1111/j.1399-6576.2006.00937.x.
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. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.