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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroscopy
Keywords: spinal anesthesia
Knee Arthroscopy
Chloroprocaine
Height
Effective Dose (ED95)
Continual Reassessment Method (CRM)
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Hôpital de Braine-l'Alleud
First posted: 2019-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia

Brief 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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Success or failure of anesthesia
timeFrame: perioperative
Secondary outcomes:
measure: Maximum level of sensory block assessed as loss of sensation to pinprick, cold
timeFrame: Until complete release of sensory block (up to 5 hours after surgery)
measure: Level of motor block assessed by the Bromage score
timeFrame: Until complete release of motor block (up to 5 hours after surgery)
measure: Side-effects (nausea, vomiting)
timeFrame: up to 5 hours after surgery
measure: Pain as assessed by Visual Analog Scale
timeFrame: up to 24 hours after surgery
measure: End time of sensory block
timeFrame: Until complete release of sensory block (up to 5 hours after surgery)
measure: Time to void
timeFrame: up to maximum 5 hours after surgery
measure: Bladder volume before first micturition
timeFrame: up to maximum 5 hours after surgery
measure: Time to eligibility for discharge defined by complete regression of sensory block
timeFrame: up to maximum 5 hours after surgery
Other outcomes:
Locations:
city: Braine-l'Alleud,
country: Belgium
facility: Braine-l'Alleud Hospital
Study officials:
affiliation: Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
name: Emmanuel Guntz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
name: Emmanuel Guntz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.