A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

January 26, 2010 updated by: Université de Montréal

Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many surgeries are performed under spinal anesthesia, including ambulatory surgeries. The standard agent used for spinal anesthesia is called bupivacaine. It's safe and effective, but has a major disadvantage. It has a long duration of action (up to 4 hours), witch can prolong unnecessarily the patient's stay in the recovery room and in hospital.

Another local anesthetic available for spinal anesthesia is 2-chloroprocaine. It has been used since many years, but some serious cases of toxicity in the 80's led to an interruption of its utilization. Those cases have been proven to be associated with the preservative agent (bisulfite) that was added and to the low pH (<3) of the drug.

Since then, 2-chloroprocaine exists in a preservative-free formulation and has been used in thousands of patients worldwide, without any problem. The major advantage of 2-chloroprocaine is its shorter duration of action, permitting a faster recovery from anesthesia, and also permitting a faster discharge from hospital (in a context of ambulatory surgery)

The purpose of this study is to compare the efficacity and the readiness for discharge (from the recovery room, and from hospital) between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia in elective ambulatory surgeries.

Patients, after consenting for the study, will be randomly assigned to the following groups:

  • spinal anesthesia with chloroprocaine 2% 40 mg (2 mL)
  • spinal anesthesia with bupivacaine 0,75% 7,5 mg (1 mL)

An "executant anesthesiologist" will be responsible for performing the spinal anesthesia, with a 25 gauge Sprotte needle, at the level L2L3, L3L4 or L4L5. The "responsible anesthesiologist" will only take charge of the patient after the technique, so he stays double-blinded to the local anesthetic used. During surgery, if the patient feels pain, he may receive iv fentanyl, 25-100 µg at every 5 minutes.

Measures will start immediately after the spinal block:

Evaluation of the sensory block height (with ice):

  • Every 3 minutes for 15 minutes (time to obtain a block a about T10)
  • Every 5 minutes for 45 minutes (surgery)
  • Every 10 minutes for 60 minutes, then every 15 minutes until the block regresses to S2 (recovery room and ambulatory surgery unit)

Evaluation of the motor block (using the Bromage scale):

  • Every 3 minutes for 15 minutes
  • At the beginning and at the end of the surgery
  • After the surgery:every 10 minutes for 60 minutes, then every 15 minutes until the block regresses to S2 (recovery room and ambulatory surgery unit)

(Bromage scale: full flexion of feet and knee = 0; able to move knee and feet, not hip = 1; able to move feet only = 2; unable to move feet or knee = 3)

When the block will have regressed to S2, the patient will be asked to urinate. If he isn't able to urinate, this demand will be repeated every 15 minutes. (not applicable if the patient goes home with a urinary catheter)

In the context of an ambulatory surgery, the patient will go home when he will meet the usual discharge criteria. All patients will receive a phone call from the research team the day after surgery, and 7 days later, to assess their satisfaction towards the analgesia and to inquire about potential complications of the spinal anesthesia.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • St-Luc Hospital CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
Drug: bupivacaine
spinal administration of bupivacaine 0,75% 7,5 mg (1 mL)
Other Names:
  • Marcaine
Active Comparator: Chloroprocaine
Drug: chloroprocaine
spinal administration of chloroprocaine 2%, 40 mg (2 mL)
Other Names:
  • Nesacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to obtain discharge criteria from recovery room
Time Frame: within the first hours (1-2 h) after the surgery
within the first hours (1-2 h) after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to obtain discharge criteria from hospital
Time Frame: within the same day of the surgery
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
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
lenght of stay in the recovery room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD07.007
  • 118046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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