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临床试验/2023-505247-39-00
2023-505247-39-00招募中3 期

Efficacy of intravenous dexamethasone in prolonging the duration of spinal anesthesia with chloroprocaine in knee arthroscopy.

Centre Medico Chirurgical Ambroise Pare Hartmann1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
60
试验地点
1
主要终点
The primary endpoint is the time to regression of sensory block by two dermatomes, defined as the time (in minutes) from the spinal puncture to the regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed every 5 minutes after spinal puncture using a pin-prick test (0-2: 0 = absent sensation; 1 = dull, decreased sensation; 2 = sharp, normal sensation).

研究概览

简要总结

The main objective is to evaluate the efficacy of IV dexamethasone to prolong the sensory block obtained by spinal anesthesia with chloroprocaine, assessed as the time to regression by two dermatomes from the highest blocked dermatome, using the pin-prick method.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • 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 including: hypersensitivity to chloroprocaine, medicinal products of the para-aminobenzoic acid (PABA) ester group, to other ester-type local anesthetics, or to any of the excipients; general and specific contraindications to spinal anesthesia regardless of the local anesthetic used (e.g. decompensated cardiac insufficiency, hypovolemic shock, severe hypovolemia, coagulopathy); intravenous regional anesthesia; serious problems with cardiac conduction; severe anemia; local infection at the puncture site or systemic infection/sepsis
  • Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) including: history of hypersensitivity reactions after administration of ketoprofen, celecoxib, aspirin or other NSAIDs (including bronchospasm/asthma, rhinitis, urticaria, angioedema, anaphylaxis); active peptic ulcer disease or active gastrointestinal bleeding; history of recurrent peptic ulcer/hemorrhage; history of gastrointestinal bleeding/ulceration/perforation related to NSAID therapy; severe renal impairment; severe hepatic impairment; severe heart failure; and for celecoxib specifically: known hypersensitivity to sulfonamides; established ischemic heart disease and/or peripheral arterial disease and/or cerebrovascular disease
  • 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
  • History of diabetes
  • Pre-existing peripheral neuropathy
  • American Society of Anesthesiologists (ASA) physical status IV
  • Contraindication to dexamethasone including: hypersensitivity to dexamethasone or to any of the excipients; systemic infection; systemic fungal infection; administration of live virus vaccines
  • Hypersensitivity of any drug used in this study
  • Long-term oral corticosteroid therapy
  • Chronic opioid use
  • Chronic pain syndromes

研究组 & 干预措施

DEXAMETHASONE VIATRIS 20 mg/5 ml, solution injectable en ampoule

Test

干预措施: DEXAMETHASONE VIATRIS 20 mg/5 ml, solution injectable en ampoule (Drug)

CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable

Placebo

干预措施: CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable (Drug)

CHLOROPROCAINE HYDROCHLORIDE

Auxiliary

干预措施: CHLOROPROCAINE HYDROCHLORIDE (Drug)

结局指标

主要结局

The primary endpoint is the time to regression of sensory block by two dermatomes, defined as the time (in minutes) from the spinal puncture to the regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed every 5 minutes after spinal puncture using a pin-prick test (0-2: 0 = absent sensation; 1 = dull, decreased sensation; 2 = sharp, normal sensation).

The primary endpoint is the time to regression of sensory block by two dermatomes, defined as the time (in minutes) from the spinal puncture to the regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed every 5 minutes after spinal puncture using a pin-prick test (0-2: 0 = absent sensation; 1 = dull, decreased sensation; 2 = sharp, normal sensation).

次要结局

  • 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 (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.
  • Highest dermatome level of sensory block achieved after the spinal puncture assessed using the pin-prick test.
  • Time (in minutes) from the spinal puncture to the highest blocked dermatome.
  • Need (or not) for an additional anesthetic procedure (sedation or general anesthesia) will be recorded only in the case of intraoperative pain at the incision site, during surgical manipulation, or during tourniquet inflation. Such cases will be considered as failures of spinal anesthesia. If sedation is administered solely for anxiety in the operating room, preventing further sensory or motor assessment, the patient will be excluded from the per-protocol analysis.
  • Time (in minutes) from the spinal puncture to regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture, assessed using the cold test. Cold sensation will be evaluated with a stainless-steel cylinder (2–4 °C). The cylinder will be applied gently for 1–2 seconds to each dermatome without pressure. The reference area (T4) will be used to define normal cold sensation.
  • Any episode occurring from spinal puncture up to 24 hours after surgery, including: hypotension, bradycardia, nausea and vomiting, pruritus, urinary retention.
  • Maximal pain score collected in the PACU using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain).
  • Total opioid consumption will be recorded and converted to oral morphine equivalents (OME, mg), including all opioids administered during the intraoperative period, in the PACU, during the ambulatory hospitalization until discharge, as well as those taken at home within 24 hours after surgery, as reported during the follow-up phone call at Day 1 (D1).
  • Pain intensity will be assessed using a Numeric Rating Scale (NRS, 0–10) at rest and during movement, and recorded during the intraoperative period (H0), in the PACU (H1 ± 30min), during the ambulatory hospitalization until discharge (H3 ± 1h and H6 ± 2h), and at home until D1 (H9 ± 2h, H12 ± 2h and H24 ± 3h).
  • Time (in minutes) between the skin incision and the last suture.
  • Post puncture headache (Yes/No) evaluated at D1.

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Cécile NAUDIN

Scientific

Centre Medico Chirurgical Ambroise Pare Hartmann

研究点 (1)

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