Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Chloroprocaine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroprocaine Group<br>Epidural anesthesia with 3% chloroprocaine. | Drug: Chloroprocaine<br>* 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.<br>* Other names: Chloroprocaine Hydrochloride;|
| Active Comparator: Lidocaine Group<br>Epidural anesthesia with 2% lidocaine. | Drug: Lidocaine<br>* 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.<br>* Other names: Lidocaine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural anesthesia, Chloroprocaine, Lidocaine