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Completed

NCT Number: NCT02287870

Epidural Anesthesia With Chloroprocaine Versus Lidocaine

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.

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Key information

Conditions

Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroprocaine

Drug

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

Other names: Chloroprocaine Hydrochloride

Lidocaine

Drug

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

Other names: Lidocaine Hydrochloride

Primary outcomes

  1. Epidural anesthesia effects of chloroprocaine versus lidocaine

    Time frame: 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 outcomes

  1. Comparison of vital signs between chloroprocaine and lidocaine groups

    Time frame: Four months (January - April, 2008)

    The vital signs are assessed by diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse oxygen saturation (SpO2).

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 11, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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