NCT00845962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 27, 2010

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

February 17, 2009

Last Update Submit

January 26, 2010

Conditions

Spinal Anesthesia

Keywords

bupivacainechloroprocainespinalanesthesiaelective surgeryambulatory surgery

Outcome Measures

Primary Outcomes (1)

  • Time to obtain discharge criteria from recovery room

    within the first hours (1-2 h) after the surgery

Secondary Outcomes (3)

  • Time to obtain discharge criteria from hospital

    within the same day of the surgery

  • The amount of additional IV analgesia (fentanyl) administered during the intraoperative period

    total length of surgery

  • The amount of iv analgesia (fentanyl and morphine) needed in the recovery room

    lenght of stay in the recovery room

Study Arms (2)

Chloroprocaine

ACTIVE COMPARATOR
Drug: chloroprocaine

Bupivacaine

ACTIVE COMPARATOR
Drug: bupivacaine

Interventions

chloroprocaineDRUG

spinal administration of chloroprocaine 2%, 40 mg (2 mL)

Also known as: Nesacaine
Chloroprocaine
bupivacaineDRUG

spinal administration of bupivacaine 0,75% 7,5 mg (1 mL)

Also known as: Marcaine
Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St-Luc Hospital CHUM

Montreal, Quebec, H2X 3J4, Canada

Location

Related Publications (12)

  • Kouri ME, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth Analg. 2004 Jan;98(1):75-80. doi: 10.1213/01.ANE.0000093228.61443.EE.

    PMID: 14693590BACKGROUND

  • Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine. Anesth Analg. 2004 Jan;98(1):81-88. doi: 10.1213/01.ANE.0000093361.48458.6E.

    PMID: 14693591BACKGROUND

  • Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 2004 Jan;98(1):89-94. doi: 10.1213/01.ANE.0000093360.02058.ED.

    PMID: 14693593BACKGROUND

  • Warren DT, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added dextrose. Anesth Analg. 2004 Jan;98(1):95-101. doi: 10.1213/01.ANE.0000093362.95618.89.

    PMID: 14693594BACKGROUND

  • Kopacz DJ. Spinal 2-chloroprocaine: minimum effective dose. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):36-42. doi: 10.1016/j.rapm.2004.09.008.

    PMID: 15690266BACKGROUND

  • Davis BR, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added clonidine. Anesth Analg. 2005 Feb;100(2):559-565. doi: 10.1213/01.ANE.0000143381.30409.62.

    PMID: 15673894BACKGROUND

  • Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.

    PMID: 15673895BACKGROUND

  • Gonter AF, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with procaine in volunteers. Anesth Analg. 2005 Feb;100(2):573-579. doi: 10.1213/01.ANE.0000143380.36298.4A.

    PMID: 15673896BACKGROUND

  • Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth Analg. 2005 Feb;100(2):553-558. doi: 10.1213/01.ANE.0000130397.38849.4A.

    PMID: 15673893BACKGROUND

  • Casati A, Danelli G, Berti M, Fioro A, Fanelli A, Benassi C, Petronella G, Fanelli G. Intrathecal 2-chloroprocaine for lower limb outpatient surgery: a prospective, randomized, double-blind, clinical evaluation. Anesth Analg. 2006 Jul;103(1):234-8, table of contents. doi: 10.1213/01.ane.0000221441.44387.82.

    PMID: 16790659BACKGROUND

  • Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.

    PMID: 17377114BACKGROUND

  • Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.

    PMID: 21203878DERIVED

MeSH Terms

Interventions

chloroprocaineBupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jean-Denis Roy, MD

    St-Luc hospital, CHUM, University of Montreal

    STUDY DIRECTOR

  • Luc Massicotte, MD

    St-Luc Hospital, CHUM, University of Montreal

    STUDY DIRECTOR

  • Marie-Andrée Lacasse, MD, resident

    St-Luc hospital, CHUM, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 27, 2010

Record last verified: 2009-07

Locations

CA(1)