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A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

This study has been completed.
Sponsor:
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00845962
First received: February 17, 2009
Last updated: January 26, 2010
Last verified: July 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to obtain discharge criteria from hospital [ Time Frame: within the same day of the surgery ] [ Designated as safety issue: No ]
  • The amount of additional IV analgesia (fentanyl) administered during the intraoperative period [ Time Frame: total length of surgery ] [ Designated as safety issue: No ]
  • The amount of iv analgesia (fentanyl and morphine) needed in the recovery room [ Time Frame: lenght of stay in the recovery room ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845962

Locations
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
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jean-Denis Roy / MD Anesthesiologist, Centre hospitalier de l'université de Montréal (CHUM) / University of Montreal
ClinicalTrials.gov Identifier: NCT00845962     History of Changes
Other Study ID Numbers: HD07.007, 118046
Study First Received: February 17, 2009
Last Updated: January 26, 2010
Health Authority: Canada: Health Canada

Keywords provided by Université de Montréal:
bupivacaine
chloroprocaine
spinal
 anesthesia
elective surgery
ambulatory surgery

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Chloroprocaine
Procaine
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013