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A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00845962
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : January 27, 2010
Sponsor:
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:
Université de Montréal

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Anesthesia Drug: chloroprocaine Drug: bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison.
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845962


Locations
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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)
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jean-Denis Roy / MD Anesthesiologist, Centre hospitalier de l'université de Montréal (CHUM) / University of Montreal
ClinicalTrials.gov Identifier: NCT00845962    
Other Study ID Numbers: HD07.007
118046
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: July 2009
Keywords provided by Université de Montréal:
bupivacaine
chloroprocaine
spinal
anesthesia
elective surgery
ambulatory surgery
Additional relevant MeSH terms:
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Anesthetics
Bupivacaine
Chloroprocaine
Procaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents