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NCT Number: 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

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

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Key information

Conditions

Knee Arthroscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Braine-l'Alleud Hospital

Braine-l'Alleud, 1420, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ampres 10mg/ml

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. Time to void

    Time frame: up to maximum 5 hours after surgery

    The time to obtain the first micturition will be noted.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Hôpital de Braine-l'Alleud

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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