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

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Braine-l'Alleud,, Belgium, 1420
        • Braine-l'Alleud Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
  • Ampres 10mg/ml
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.
The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
  • Ampres 10mg/ml
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.
The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other Names:
  • Ampres 10mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Level of motor block assessed by the Bromage score
Time Frame: Until complete release of motor block (up to 5 hours after surgery)
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)
Side-effects (nausea, vomiting)
Time Frame: up to 5 hours after surgery
Nausea and vomiting are treated in the PACU and the post operative unit.
up to 5 hours after surgery
Pain as assessed by Visual Analog Scale
Time Frame: up to 24 hours after surgery
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
End time of sensory block
Time Frame: Until complete release of sensory block (up to 5 hours after surgery)
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)
Time to void
Time Frame: up to maximum 5 hours after surgery
The time to obtain the first micturition will be noted.
up to maximum 5 hours after surgery
Bladder volume before first micturition
Time Frame: up to maximum 5 hours after surgery
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
Time to eligibility for discharge defined by complete regression of sensory block
Time Frame: up to maximum 5 hours after surgery
Time of discharge of the patient from the hospital.
up to maximum 5 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2019

Primary Completion (ACTUAL)

August 16, 2019

Study Completion (ACTUAL)

August 17, 2019

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Arthroscopy

Clinical Trials on Isobaric 2-chloroprocaine

3
Subscribe