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

NCT ID: NCT03882489

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2019-08-17

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

Conditions

Knee Arthroscopy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Isobaric 2-chloroprocaine

Intervention Type: DRUG

The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.

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.

Isobaric 2-chloroprocaine

Intervention Type: DRUG

The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.

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.

Isobaric 2-chloroprocaine

Intervention Type: DRUG

The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.

Interventions

Isobaric 2-chloroprocaine

The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.

Intervention Type: DRUG

Other Intervention Names

Ampres 10mg/ml

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital de Braine-l'Alleud

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Guntz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital

Emmanuel Guntz

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital

Locations

Braine-l'Alleud Hospital

Braine-l'Alleud, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 27710984 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23521140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14933832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15673895 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15673896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17377114 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35695753 (View on PubMed)

Other Identifiers

B076201836762

Identifier Type: -

Identifier Source: org_study_id