Knee ArthroscopyNCT03882489
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
An observational study of Knee Arthroscopy, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthroscopy
- What is being tested?
- Isobaric 2-chloroprocaine
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Apr 2019to 17 Aug 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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
- Conditions
- Knee Arthroscopy
- Being tested
- Isobaric 2-chloroprocaine
- Keywords
- spinal anesthesia, Knee Arthroscopy, Chloroprocaine, Height, Effective Dose (ED95), Continual Reassessment Method (CRM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobaric 2-chloroprocaineDrug
Also called Ampres 10mg/ml
The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Isobaric 2-chloroprocaine | |
| 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. Receives: Drug: Isobaric 2-chloroprocaine | |
| 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. Receives: Drug: Isobaric 2-chloroprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of anesthesia
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.
Measured: perioperative
Secondary outcomes (8)
Maximum level of sensory block assessed as loss of sensation to pinprick, cold
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.
Measured: Until complete release of sensory block (up to 5 hours after surgery)
Level of motor block assessed by the Bromage score
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.
Measured: Until complete release of motor block (up to 5 hours after surgery)
Side-effects (nausea, vomiting)
Nausea and vomiting are treated in the PACU and the post operative unit.
Measured: up to 5 hours after surgery
Pain as assessed by Visual Analog Scale
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)
Measured: up to 24 hours after surgery
End time of sensory block
The patient is asked to note the time at which he/she feels that he/she has regained a strictly normal sensitivity
Measured: Until complete release of sensory block (up to 5 hours after surgery)
Time to void
The time to obtain the first micturition will be noted.
Measured: up to maximum 5 hours after surgery
Bladder volume before first micturition
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.
Measured: up to maximum 5 hours after surgery
Time to eligibility for discharge defined by complete regression of sensory block
Time of discharge of the patient from the hospital.
Measured: up to maximum 5 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start11 Apr 2019
- Primary completion16 Aug 2019
- Study completion17 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud
- Responsible party
- Sponsor
- Investigators
- Emmanuel Guntz, MD, PhD, Principal investigator, Université Libre de Bruxelles (ULB), Braine-l'Alleud HospitalEmmanuel Guntz, Principal investigator, Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882489
- Sponsor's protocol ID
- B076201836762
- Status last verified
- Oct 2019
- First submitted
- 18 Mar 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27710984Forster 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.
PubMed 23521140FOLDES 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.
PubMed 14933832Yoos 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 15673896Casati 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 17377114Guntz 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.
PubMed 35695753
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03882489
- Acronym / sponsor ID
- B076201836762
- Conditions
- Knee Arthroscopy
- Keywords
- spinal anesthesia, Knee Arthroscopy, Chloroprocaine, Height, Effective Dose (ED95), Continual Reassessment Method (CRM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 17 Aug 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : Height 150-165 cm | – | Drug: Isobaric 2-chloroprocaineDose-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. |
| Cohort 2 : Height 166-180 cm | – | Drug: Isobaric 2-chloroprocaineDose-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. |
| Cohort 3 : Height 181-195 cm | – | Drug: Isobaric 2-chloroprocaineDose-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Isobaric 2-chloroprocaineAlso: Ampres 10mg/mlThe doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects. | Drug | Cohort 1 : Height 150-165 cm, Cohort 2 : Height 166-180 cm, Cohort 3 : Height 181-195 cm |
Primary outcome
Success or failure of anesthesia
Time frame: perioperative
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.
8 secondary outcomes
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)
Level of motor block assessed by the Bromage score
Time frame: Until complete release of motor block (up to 5 hours after surgery)
Side-effects (nausea, vomiting)
Time frame: up to 5 hours after surgery
Pain as assessed by Visual Analog Scale
Time frame: up to 24 hours after surgery
End time of sensory block
Time frame: Until complete release of sensory block (up to 5 hours after surgery)
Time to void
Time frame: up to maximum 5 hours after surgery
Bladder volume before first micturition
Time frame: up to maximum 5 hours after surgery
Time to eligibility for discharge defined by complete regression of sensory block
Time frame: up to maximum 5 hours after surgery
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 7 Oct 2019.
- Background: PubMed 27710984Yu 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.
- Background: PubMed 23521140Forster 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.
- Background: PubMed 14933832FOLDES 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.
- 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 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 35695753Guntz 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.
- Individual participant dataSharing planned: Undecided
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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.
Emmanuel Guntz, MD, PhD principal investigator
Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
Emmanuel Guntz principal investigator
Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroscopy, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 5 inclusion and 5 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 7 Oct 2019. 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 Belgium. 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?
Success or failure of anesthesia (time frame: perioperative). 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 NCT03882489, which also lists 7 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 7 Oct 2019.