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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCMC Ambroise Paré

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Contraindications to spinal anesthesia with intrathecal chloroprocaine

History of diabetes,

Pre-existing peripheral neuropathy,

American Society of Anesthesiologists (ASA) physical status IV,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • Chloroprocaine Injection [Clorotekal]

    Drug

    Spinal anesthesia with chloroprocaine 40 mg

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CHLOROPlacebo comparator 2 interventions
Group B: CHLORODEXExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Up to 2 hours following spinal anesthesia

Secondary outcomes

1

Time to complete resolution of motor block

Time (in minutes) from the spinal puncture to complete recovery of motor block, assessed by the Modified Bromage Scale (0-3: 0 = full flexion of hip, knee, and ankle; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = no movement of hip, knee, or ankle). Motor block will be assessed every 5 minutes after the spinal puncture until regression of the sensory block by two dermatomes, and then every 10 minutes until complete motor recovery (Bromage 0).

Time frame
Up to 8 hours following spinal anesthesia
2

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

Time (in minutes) from the spinal puncture to regression of four dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed using the pin-prick test every 5 minutes after the spinal puncture until regression by two dermatomes, and then every 10 minutes until regression by four dermatomes. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.

Time frame
Up to 8 hours following spinal anesthesia
3

Maximum sensory block level

Highest dermatome level of sensory block achieved after the spinal puncture (pin-prick test).

Time frame
Up to 30 minutes following spinal anesthesia
4

Time to maximum sensory block level

Time (in minutes) from the spinal puncture to the highest blocked dermatome (pin-prick test).

Time frame
Up to 30 minutes following spinal anesthesia

Other outcomes

Sponsors and contacts

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