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

NCT03882489 | Completed

• 1 other identifier: B076201836762
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

spinal anesthesia; Knee Arthroscopy; Chloroprocaine; Height; Effective Dose (ED95); Continual Reassessment Method (CRM)

Outcome Measures

Primary Outcomes (1)

• 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.

  perioperative

Secondary Outcomes (8)

• Maximum level of sensory block assessed as loss of sensation to pinprick, cold

  Until complete release of sensory block (up to 5 hours after surgery)

• Level of motor block assessed by the Bromage score

  Until complete release of motor block (up to 5 hours after surgery)

• Side-effects (nausea, vomiting)

  up to 5 hours after surgery

• Pain as assessed by Visual Analog Scale

  up to 24 hours after surgery

• End time of sensory block

  Until complete release of sensory block (up to 5 hours after surgery)

Study Arms (3)

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.

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.

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.

Drug: Isobaric 2-chloroprocaine

Interventions

Isobaric 2-chloroprocaine DRUG

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

Also known as: Ampres 10mg/ml

Cohort 1 : Height 150-165 cm; Cohort 2 : Height 166-180 cm; Cohort 3 : Height 181-195 cm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Hôpital de Braine-l'Alleud: collaborator

Study Sites (1)

Braine-l'Alleud Hospital

Braine-l'Alleud, 1420, Belgium

Location

Related Publications (7)

• 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.

  PMID: 27710984 BACKGROUND

• 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.

  PMID: 23521140 BACKGROUND

• 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.

  PMID: 14933832 BACKGROUND

• 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.

  PMID: 15673895 BACKGROUND

• 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.

  PMID: 15673896 BACKGROUND

• 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.

  PMID: 17377114 BACKGROUND

• 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.

  PMID: 35695753 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: April 11, 2019
• Primary Completion: August 16, 2019
• Study Completion: August 17, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

BE (1)