Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy: a Double-blind, Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to regression of sensory block by two dermatomes (pin-prick test)
研究概览
简要总结
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.
详细描述
This is a monocenter, prospective, randomized (1:1 ratio), controlled, parallel-group, double-blind, phase III superiority trial assessing the efficacy and the safety of IV dexamethasone for prolonging sensory block in patients undergoing knee arthroscopy under spinal anesthesia with chloroprocaine.
Participants will be randomly allocated into two groups:
- Group CHLORO (control group): Patients will receive spinal anesthesia with chloroprocaine 40mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes.
- Group CHLORODEX (experimental group): Patients will receive spinal anesthesia with chloroprocaine 40 mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an 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.
To ensure blinding, study infusions (saline or dexamethasone) will be prepared in identical 100 mL bags and labelled by a pharmacy staff member or an "outside protocol" healthcare professional (physician or nurse) not involved in patient care or assessment.
The infusion will start approximately 10-15 minutes before the spinal punction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CHLORO
Normal saline solution IV infusion
干预措施: Sodium Chloride 0.9% (Drug)
CHLORODEX
Dexamethasone IV infusion
干预措施: Dexamethasone (Drug)
CHLORODEX
Dexamethasone IV infusion
干预措施: Chloroprocaine Injection [Clorotekal] (Drug)
CHLORO
Normal saline solution IV infusion
干预措施: Chloroprocaine Injection [Clorotekal] (Drug)
结局指标
主要结局
Time to regression of sensory block by two dermatomes (pin-prick test)
时间窗: 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.
次要结局
- Time to regression of sensory block by two dermatomes (cold test)(Up to 2 hours 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)
- 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)
- Incidence of hypotension(From spinal anesthesia to 24 hours after surgery)
- Incidence of bradycardia(From spinal anesthesia to 24 hours after surgery)
- Incidence of nausea(From spinal anesthesia to 24 hours after surgery)
- Incidence of vomiting(From spinal anesthesia to 24 hours after surgery)
- Incidence of pruritus(From spinal anesthesia to 24 hours after surgery)
- Incidence of urinary retention(From spinal anesthesia to 24 hours after surgery)
- Maximal pain score in the PACU(Up to 6 hours following spinal anesthesia)
- Total opioid consumption(From spinal anesthesia to 24 hours after surgery)
- Pain intensity(From spinal anesthesia to 24 hours after surgery)
- Duration of surgery(Intraoperative period)
- Incidence of post-puncture headache(From spinal anesthesia to 24 hours after surgery)