Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Sponsor

Jinling Hospital, China (Other)

Overall Status

Completed

CT.gov ID

NCT02287870

Collaborator

(none)

120

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Chloroprocaine Drug: Lidocaine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroprocaine Group Epidural anesthesia with 3% chloroprocaine.	Drug: Chloroprocaine 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine. Other Names: Chloroprocaine Hydrochloride
Active Comparator: Lidocaine Group Epidural anesthesia with 2% lidocaine.	Drug: Lidocaine 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine. Other Names: Lidocaine Hydrochloride

Arm

Intervention/Treatment

Experimental: Chloroprocaine Group

Epidural anesthesia with 3% chloroprocaine.

Drug: Chloroprocaine

60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.

Other Names:

Chloroprocaine Hydrochloride

Active Comparator: Lidocaine Group

Epidural anesthesia with 2% lidocaine.

Drug: Lidocaine

60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.

Other Names:

Lidocaine Hydrochloride

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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