- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882489
Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy
Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy : Dose-finding Study Based on the Continual Reassessment Method (CRM)
In ambulatory surgery, the choice of the local anesthetic used is essential. The ideal local anesthetic must allow a quick installation of the spinal block, a duration of the sensory block adapted to the surgery with a minimum of side effects. These side effects include bradycardia, hypotension and block failure during the intraoperative period; bladder retention, transient neurological disorders during the post-operative period. The achievement of kinetic objectives associated with a reduction in side effects is related to the choice of local anesthetic and the dose administered. However, there are interindividual pharmacokinetic variations that make it difficult to predict the effective dose and the unfortunate occurrence of side effects.
In this context, the height of the patient is a criterion involved in the level, the duration of the sensitive motor block and therefore the side effects
The local anesthetic of the amino ester family, isobaric 2-chloroprocaine (2-CP) has been successfully used for spinal anesthesia since several decades. With a short duration of action, it is preferred to other anesthetics for the short-term outpatient surgeries. However, the effective dose 95 (ED95) of intrathecal isobaric 2-CP is currently unknown.
The purpose of this prospective study is to determine the ED95 of the spinal 2-CP using the continuous re-evaluation method (Continual Reassessment Method) (CRM) based on patient's height
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Braine-l'Alleud,, Belgium, 1420
- Braine-l'Alleud Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- signed informed consent
- scheduled outpatient knee arthroscopy
- between 18 and 80 years old
- American Society of Anesthesiologists physical status (ASA) < III
- Height between 150 and 195 cm
Exclusion Criteria:
- cardiac pathology (such as heart failure, aortic stenosis)
- coagulation disorder (International Normalized Ratio (INR) > 1.3, platelets<80.000/mm3)
- known allergy to local anaesthetics
- central and peripheral neuropathies
- patient's refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cohort 1 : Height 150-165 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort.
The cohort 1 includes patients whose the height is between 150 and 165 cm.
To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 40 mg in the cohort 1 for the first 4 subjects.
For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects.
Doses will be staggered from 25 to 50 mg for cohort 1.
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The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
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Cohort 2 : Height 166-180 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort.
The cohort 2 includes patients whose the height is between 166 and 180 cm.
To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 45 mg in the cohort 2 for the first 4 subjects.
For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects.
Doses will be staggered from 30 to 55 mg for cohort 2.
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The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
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Cohort 3 : Height 181-195 cm
Dose-finding study with 4 subjects per dose and a maximum of 40 patients by cohort.
The cohort 3 includes patients whose the height is between 166 and 180 cm.
To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), isobaric 2-chloroprocaine will be administrated at the dose initial of 50 mg in the cohort 3 for the first 4 subjects.
For the next subjects, the doses to administrate will vary 5 mg (0.5 ml) and will be determined by the Continual Reassessment Method (CRM) according to the observed responses in the previous subjects.
Doses will be staggered from 35 to 60 mg for cohort 3.
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The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Success or failure of anesthesia
Time Frame: perioperative
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The anesthesia will be considered as a success if there is an extension of the sensory block to the Th12 dermatome after inflation of the tourniquet, absence of pain during tourniquet inflation, incision and overall surgery. Or the anesthesia will be considered as a failure if there is an absence of extension of the sensory block at the Th12 dermatome, pain at the tourniquet inflation, at the incision, or during surgery. |
perioperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum level of sensory block assessed as loss of sensation to pinprick, cold
Time Frame: Until complete release of sensory block (up to 5 hours after surgery)
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The level of sensory block will be assessed as loss of sensation to pinprick and cold at 5, 10, 20 and 30 minutes after the intrathecal injection (corresponding to time 0), every 10 minutes in the Post Anesthesia Care Unit (PACU) and every 30 minutes after PACU discharge.
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Until complete release of sensory block (up to 5 hours after surgery)
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Level of motor block assessed by the Bromage score
Time Frame: Until complete release of motor block (up to 5 hours after surgery)
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The level of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection (corresponding to time 0) and every 10 minutes in the post-anesthesia care unit (PACU).
The level of motor block will be assessed by using the Bromage Scale.
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Until complete release of motor block (up to 5 hours after surgery)
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Side-effects (nausea, vomiting)
Time Frame: up to 5 hours after surgery
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Nausea and vomiting are treated in the PACU and the post operative unit.
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up to 5 hours after surgery
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Pain as assessed by Visual Analog Scale
Time Frame: up to 24 hours after surgery
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Pain levels will be determined at tourniquet inflation, incision, every 10 minutes in the post-anesthesia care unit (PACU), every 30 minutes after PACU discharge and 24h after the surgery at home (by phone).
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
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up to 24 hours after surgery
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End time of sensory block
Time Frame: Until complete release of sensory block (up to 5 hours after surgery)
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The patient is asked to note the time at which he/she feels that he/she has regained a strictly normal sensitivity
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Until complete release of sensory block (up to 5 hours after surgery)
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Time to void
Time Frame: up to maximum 5 hours after surgery
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The time to obtain the first micturition will be noted.
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up to maximum 5 hours after surgery
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Bladder volume before first micturition
Time Frame: up to maximum 5 hours after surgery
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An evacuating bladder catheterization is performed when a bladder volume greater than 600 mL, confirmed by a Bladderscan device, is associated with the following signs and/or symptoms: hypogastric pain, anuria or overflow urination.
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up to maximum 5 hours after surgery
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Time to eligibility for discharge defined by complete regression of sensory block
Time Frame: up to maximum 5 hours after surgery
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Time of discharge of the patient from the hospital.
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up to maximum 5 hours after surgery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Emmanuel Guntz, MD, PhD, Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
- Principal Investigator: Emmanuel Guntz, Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
Publications and helpful links
General Publications
- FOLDES FF, McNALL PG. 2-Chloroprocaine: a new local anesthetic agent. Anesthesiology. 1952 May;13(3):287-96. doi: 10.1097/00000542-195205000-00009. No abstract available.
- Yu X, Zhang F. The effect of parturient height on the median effective dose of intrathecally administered ropivacaine. Ann Saudi Med. 2016 Sep-Oct;36(5):328-333. doi: 10.5144/0256-4947.2016.328.
- Forster JG, Rosenberg PH, Harilainen A, Sandelin J, Pitkanen MT. Chloroprocaine 40 mg produces shorter spinal block than articaine 40 mg in day-case knee arthroscopy patients. Acta Anaesthesiol Scand. 2013 Aug;57(7):911-9. doi: 10.1111/aas.12107. Epub 2013 Mar 25.
- 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.
- 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.
- 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.
- Guntz E, Jeanne G, Gouwy J, M'rini M, Saxena S, Fils JF, Kapessidou Y. Influence of height on ED95 of intrathecal 2-chloroprocaine for knee arthroscopy: A prospective dose-response clinical trial. Eur J Anaesthesiol. 2022 Jul 1;39(7):602-610. doi: 10.1097/EJA.0000000000001692. Epub 2022 Jun 10.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B076201836762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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