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

NCT07674576 | Not Yet Recruiting Phase 3

• 2 other identifiers: 2023/012023-505247-39-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthroscopy

Keywords

Knee arthroscopy; dexamethasone; chloroprocaine; spinal anesthesia; sensory block; motor block

Outcome Measures

Primary Outcomes (1)

• Time to regression of sensory block by two dermatomes (pin-prick test)

  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.

  Up to 2 hours following spinal anesthesia

Secondary Outcomes (17)

• Time to complete resolution of motor block

  Up to 8 hours following spinal anesthesia

• Time to regression of sensory block by four dermatomes (pin-prick test)

  Up to 8 hours following spinal anesthesia

• Maximum sensory block level

  Up to 30 minutes following spinal anesthesia

• Time to maximum sensory block level

  Up to 30 minutes following spinal anesthesia

• Need for additional anesthetic procedure

  From spinal anesthesia to the end of surgery

Study Arms (2)

CHLORO

PLACEBO COMPARATOR

Normal saline solution IV infusion

Drug: Sodium Chloride 0.9%; Drug: Chloroprocaine Injection [Clorotekal]

CHLORODEX

EXPERIMENTAL

Dexamethasone IV infusion

Drug: Dexamethasone; Drug: Chloroprocaine Injection [Clorotekal]

Interventions

Sodium Chloride 0.9% DRUG

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

CHLORO

Dexamethasone DRUG

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

CHLORODEX

Chloroprocaine Injection [Clorotekal] DRUG

Spinal anesthesia with chloroprocaine 40 mg

CHLORO; CHLORODEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Clinique Drouot Rémusat

Paris, Île-de-France Region, 75016, France

Location

MeSH Terms

Interventions

Sodium Chloride; Dexamethasone; chloroprocaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Sébastien BLOC, MD

CONTACT

01 44 14 11 11; sebebloc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

FR (1)