Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Chloroprocaine; Drug: Lidocaine

• Registration Number: NCT02287870
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-04
• Study Completion: 2008-06
• Status Verified: 2014-11
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-10
• Last Update Submitted: 2014-11-10
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroprocaine Group	Chloroprocaine	Epidural anesthesia with 3% chloroprocaine.
Lidocaine Group	Lidocaine	Epidural anesthesia with 2% lidocaine.

Primary Outcome Measures

Name	Time	Method
Epidural anesthesia effects of chloroprocaine versus lidocaine	Four months (January - April, 2008)	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of vital signs between chloroprocaine and lidocaine groups	Four months (January - April, 2008)	The vital signs are assessed by diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse oxygen saturation (SpO2).