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Epidural Anesthesia With Chloroprocaine Versus Lidocaine

J

Jinling Hospital, China

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Chloroprocaine
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02287870
2007NLY-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

120 participants in 2 patient groups

Chloroprocaine Group
Experimental group
Description:
Epidural anesthesia with 3% chloroprocaine.
Treatment:
Drug: Chloroprocaine
Lidocaine Group
Active Comparator group
Description:
Epidural anesthesia with 2% lidocaine.
Treatment:
Drug: Lidocaine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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