Spinal AnesthesiaNCT00845962
A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia
A study testing chloroprocaine and bupivacaine in people with Spinal Anesthesia, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- chloroprocaine and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Anesthesia
- Being tested
- chloroprocaine, bupivacaine
- Keywords
- bupivacaine, chloroprocaine, spinal, anesthesia, elective surgery, ambulatory surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroprocaineDrug
Also called Nesacaine
spinal administration of chloroprocaine 2%, 40 mg (2 mL)
bupivacaineDrug
Also called Marcaine
spinal administration of bupivacaine 0,75% 7,5 mg (1 mL)
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Active comparator | Not described Receives: Drug: chloroprocaine |
| Bupivacaine | Active comparator | Not described Receives: Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtain discharge criteria from recovery room
Measured: within the first hours (1-2 h) after the surgery
Secondary outcomes (3)
Time to obtain discharge criteria from hospital
Measured: within the same day of the surgery
The amount of additional IV analgesia (fentanyl) administered during the intraoperative period
Measured: total length of surgery
The amount of iv analgesia (fentanyl and morphine) needed in the recovery room
Measured: lenght of stay in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Denis Roy, MD, Study director, St-Luc hospital, CHUM, University of MontrealLuc Massicotte, MD, Study director, St-Luc Hospital, CHUM, University of MontrealMarie-Andrée Lacasse, MD, resident, Principal investigator, St-Luc hospital, CHUM, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845962
- Sponsor's protocol ID
- HD07.007
- Other IDs
- 118046
- Status last verified
- Jul 2009
- First submitted
- 17 Feb 2009
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14693590Smith 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.
PubMed 14693591Vath 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.
PubMed 14693593Warren 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.
PubMed 14693594Kopacz 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.
PubMed 15690266Davis 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.
PubMed 15673894Yoos 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.
PubMed 15673895Gonter 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.
PubMed 15673896Yoos 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.
PubMed 15673893Casati 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.
PubMed 16790659Casati 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.
PubMed 17377114Lacasse 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.
PubMed 21203878
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison.
- ClinicalTrials.gov ID
- NCT00845962
- Acronym / sponsor ID
- HD07.007
- Conditions
- Spinal Anesthesia
- Keywords
- bupivacaine, chloroprocaine, spinal, anesthesia, elective surgery, ambulatory surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | Active comparator | Drug: chloroprocaine |
| Bupivacaine | Active comparator | Drug: bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroprocaineAlso: Nesacainespinal administration of chloroprocaine 2%, 40 mg (2 mL) | Drug | Chloroprocaine |
| bupivacaineAlso: Marcainespinal administration of bupivacaine 0,75% 7,5 mg (1 mL) | Drug | Bupivacaine |
Primary outcome
Time to obtain discharge criteria from recovery room
Time frame: within the first hours (1-2 h) after the surgery
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Background: PubMed 14693590Kouri 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.
- Background: PubMed 14693591Smith 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.
- Background: PubMed 14693593Vath 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.
- Background: PubMed 14693594Warren 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.
- Background: PubMed 15690266Kopacz 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.
- Background: PubMed 15673894Davis 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.
- Background: PubMed 15673895Yoos 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.
- Background: PubMed 15673896Gonter 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.
- Background: PubMed 15673893Yoos 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.
- Background: PubMed 16790659Casati 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.
- Background: PubMed 17377114Casati 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.
- Derived from this study: PubMed 21203878Lacasse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Denis Roy, MD study director
St-Luc hospital, CHUM, University of Montreal
Luc Massicotte, MD study director
St-Luc Hospital, CHUM, University of Montreal
Marie-Andrée Lacasse, MD, resident principal investigator
St-Luc hospital, CHUM, University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chloroprocaine and bupivacaine in people with Spinal Anesthesia, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to obtain discharge criteria from recovery room (time frame: within the first hours (1-2 h) after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845962, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2010.