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A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

This study has been completed.
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:
Université de Montréal Identifier:
First received: February 17, 2009
Last updated: January 26, 2010
Last verified: July 2009
The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.

Condition Intervention
Spinal Anesthesia Drug: chloroprocaine Drug: bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison.

Resource links provided by NLM:

Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Time to obtain discharge criteria from recovery room [ Time Frame: within the first hours (1-2 h) after the surgery ]

Secondary Outcome Measures:
  • Time to obtain discharge criteria from hospital [ Time Frame: within the same day of the surgery ]
  • The amount of additional IV analgesia (fentanyl) administered during the intraoperative period [ Time Frame: total length of surgery ]
  • The amount of iv analgesia (fentanyl and morphine) needed in the recovery room [ Time Frame: lenght of stay in the recovery room ]

Enrollment: 106
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chloroprocaine Drug: chloroprocaine
spinal administration of chloroprocaine 2%, 40 mg (2 mL)
Other Name: Nesacaine
Active Comparator: Bupivacaine Drug: bupivacaine
spinal administration of bupivacaine 0,75% 7,5 mg (1 mL)
Other Name: Marcaine

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients aged 18 years and older
  • urologic elective ambulatory procedure. For example:cystoscopy, circumcision,transurethral bladder tumor resection, varicocele and hydrocele surgery
  • gynecologic elective ambulatory procedure. For example: hysteroscopy, vulvar ou vaginal biopsy
  • general surgery elective ambulatory procedure. For example:inguinal herniorraphy, short ano-rectal procedure

Exclusion Criteria:

  • INR > 1,3
  • platelet < 75 000
  • concomitant drugs: clopidogrel (last dose < 7 days), iv heparin, low molecular weight heparin (last dose < 24 hours)
  • neurologic disease: spinal stenosis, symptomatic lumbar herniated disc, multiple sclerosis
  • liquid restriction (cardiac or renal insufficiency)
  • allergy or intolerance to chloroprocaine, bupivacaine or PABA
  • atypical plasma cholinesterase or deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00845962

Canada, Quebec
St-Luc Hospital CHUM
Montreal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
Study Director: Jean-Denis Roy, MD St-Luc hospital, CHUM, University of Montreal
Study Director: Luc Massicotte, MD St-Luc Hospital, CHUM, University of Montreal
Principal Investigator: Marie-Andrée Lacasse, MD, resident St-Luc hospital, CHUM, University of Montreal
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean-Denis Roy / MD Anesthesiologist, Centre hospitalier de l'université de Montréal (CHUM) / University of Montreal Identifier: NCT00845962     History of Changes
Other Study ID Numbers: HD07.007
Study First Received: February 17, 2009
Last Updated: January 26, 2010

Keywords provided by Université de Montréal:
elective surgery
ambulatory surgery

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents processed this record on June 23, 2017