Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy

NCT07674576 · tracked via the Priya Life Science France tracker

Sponsor

CMC Ambroise Paré

Phase

Phase 3

Started

2026-09-01

Last updated

2026-06-29

Condition(s) studied

Knee Arthroscopy

Investigational drug(s) / intervention(s)

Sodium Chloride 0.9%Dexamethasone →Chloroprocaine Injection [Clorotekal]

Sodium Chloride 0.9%: IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes

Dexamethasone: IV infusion of dexamethasone at a dose of 0.15 mg/kg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes

Chloroprocaine Injection [Clorotekal]: Spinal anesthesia with chloroprocaine 40 mg

Study summary

Chloroprocaine is a short-acting local anesthetic that allows rapid recovery and early ambulation but is currently recommended for procedures lasting 40 minutes or less.

Dexamethasone is commonly used during anesthesia for the prevention of postoperative nausea and vomiting and has also been shown to prolong the duration of analgesia and sensory block after regional anesthesia.

Dexamethasone may therefore extend the duration of chloroprocaine spinal anesthesia, potentially allowing its use for longer surgical procedures while maintaining the benefits of rapid postoperative recovery.

This study aims to evaluate whether intravenous dexamethasone can prolong the effects of spinal anesthesia performed with chloroprocaine in adults undergoing knee arthroscopy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery), * Signed written informed consent form, * Affiliation to a social security system, * Negative pregnancy test on the day of procedure for non-menopausal patients. Exclusion Criteria: * Contraindications to spinal anesthesia with intrathecal chloroprocaine * History of diabetes, * Pre-existing peripheral neuropathy, * American Society of Anesthesiologists (ASA) physical status IV, * Contraindication to dexamethasone, * Hypersensitivity of any drug used in this study, * Long-term oral corticosteroid therapy, * Chronic opioid use, * Chronic pain syndromes, * Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) * Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty), * Mental or linguistic inability to understand the study, * Patients under legal protection (guardianship, curatorship or safeguard of justice), * Patients currently included or planning to be included in another interventional study, * Pregnant or breastfeeding women, * Women of childbearing potential not using effective contraception.

Primary outcome measure(s)

Time to regression of sensory block by two dermatomes (pin-prick test) — Up to 2 hours following spinal anesthesia
Time (in minutes) from the spinal puncture to the first assessment at which the sensory block has regressed by two dermatomes from the maximum (highest/most cephalad) dermatome level of sensory block achieved after the puncture, assessed with the pin-prick test. Sensory testing will be performed every 5 minutes until two-dermatome regression is observed. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.

Trial sites (1)

Facility	City	Region	Status
Clinique Drouot Rémusat	Paris	Île-de-France Region

More CMC Ambroise Paré trials in France

Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry Recruiting

Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial Recruiting

Impact of Dialysis on Sexuality. Recruiting

Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest Recruiting

Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock Recruiting

Other trials for the same condition

Outpatient Total Knee Arthroscopy (TKA): Comparison of Postoperative Recovery Versus a Conventional Hospitalization Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07674576 on ClinicalTrials.gov ↗ ← All trials in France