Epidural Anesthesia With Chloroprocaine Versus Lidocaine

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02287870

Enrollment

120

Registered

2014-11-11

Start date

2008-01-31

Completion date

2008-06-30

Last updated

2014-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Epidural anesthesia, Chloroprocaine, Lidocaine

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.

Interventions

DRUGChloroprocaine

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

DRUGLidocaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026