We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845962
First Posted: February 18, 2009
Last Update Posted: January 27, 2010
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.
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:
Université de Montréal
  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
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.

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
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:

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
First Submitted: February 17, 2009
First Posted: February 18, 2009
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:
Anesthetics
Bupivacaine
Chloroprocaine
Procaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents