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

Knee Arthroscopy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882489
• Other study ID #: B076201836762
• Status: Completed
• Start date: April 11, 2019
• Est. completion date: August 17, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 17, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroscopy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Braine-l'Alleud Hospital	Braine-l'Alleud,

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Hôpital de Braine-l'Alleud

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View Citation

FOLDES FF, McNALL PG. 2-Chloroprocaine: a new local anesthetic agent. Anesthesiology. 1952 May;13(3):287-96. — View Citation

Förster JG, Rosenberg PH, Harilainen A, Sandelin J, Pitkänen 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. — View Citation

Gonter AF, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with procaine in volunteers. Anesth Analg. 2005 Feb;100(2):573-9. — View Citation

Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-72. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Until complete release of sensory block (up to 5 hours after surgery)
Secondary	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.	Until complete release of motor block (up to 5 hours after surgery)
Secondary	Side-effects (nausea, vomiting)	Nausea and vomiting are treated in the PACU and the post operative unit.	up to 5 hours after surgery
Secondary	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)	up to 24 hours after surgery
Secondary	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	Until complete release of sensory block (up to 5 hours after surgery)
Secondary	Time to void	The time to obtain the first micturition will be noted.	up to maximum 5 hours after surgery
Secondary	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.	up to maximum 5 hours after surgery
Secondary	Time to eligibility for discharge defined by complete regression of sensory block	Time of discharge of the patient from the hospital.	up to maximum 5 hours after surgery