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Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor (PAROCAINE)

2026年9月4日 更新者:Centre Hospitalier Universitaire de Nīmes

Evaluation of the Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor - A Single-center Prospective Cohort Study.

There has been a paradigm shift toward less invasive surgical techniques for parotidectomies, primarily to mitigate post-surgical complications. However, preserving more parotid tissue than with traditional methods can lead to an increased incidence of salivary fistulas and sialoceles after parotidectomy. The incidence of sialoceles varies considerably from 4.9% to 39%, while salivary fistula rates after parotidectomy range from 1% to 21%. Other wound complications, such as wound dehiscence, inflammation, and infection, can also occur, typically within the first month following surgery. No preventive technique has yet demonstrated clear efficacy or superiority in clinical practice.

Bupivacaine is an amino-amide commonly used for local anesthesia. With its long-acting anesthetic effects, bupivacaine blocks the autonomic pathways (parasympathetic and sympathetic), then the sensory pathways, and finally the motor pathways. By providing prolonged blockade of the parasympathetic nerve pathways that induce salivary secretion, bupivacaine injected into the parotid tissue during surgery could be a potentially effective prophylactic agent for preventing salivary fistulas after parotidectomy. Certain adjuvants can be used locally in combination with bupivacaine to prolong the duration of nerve blocks and improve postoperative pain management. Dexamethasone is the most effective adjuvant to long-acting local anesthetics. This combination is widely used in routine practice.

Due to its sustained blockade of parasympathetic nerve fibers, intraparotid bupivacaine, combined with local dexamethasone, could be an effective tool for reducing various postoperative complications, including sialoceles and salivary fistulas, after partial parotidectomy. It could also play a major role in postoperative analgesia. Although bupivacaine is commonly used in surgical practice, there are no data regarding the injection of bupivacaine combined with dexamethasone into the parotid tissue to prevent salivary complications after partial parotidectomy. Therefore, the safety of its use when injected specifically into the parotid tissue has never been evaluated.

The aim of this pilot study is to assess the tolerability of intraparotid injection of bupivacaine combined with a local injection of dexamethasone after partial parotidectomy for a benign tumor.

研究概览

研究类型

介入性

注册 (估计的)

10

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Nîmes、法国、30000
        • 招聘中
        • Centre Hospitalier de Nimes
        • 接触:
        • 首席研究员:
          • Benjamin Lallemant

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Validated surgical indication for partial parotidectomy for parotid tumor.
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

  • The subject is in a period of exclusion determined by a previous study
  • The patient is under safeguard of justice or state guardianship
  • History of allergic reaction to amino-amide-type local anesthetics.
  • Severe neurological history (epilepsy, peripheral neuropathies).
  • High-risk cardiovascular history (severe hypertension, arrhythmias, complete or incomplete heart block, heart failure, coronary artery disease, treatment with type 2 antiarrhythmic drugs).
  • Severe liver or kidney disease (severe liver failure or severe kidney failure).
  • Acidosis, sepsis.
  • Pregnant or breastfeeding patient.
  • Patient unable to give informed consent.
  • Patient for whom it is impossible to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Patients who undergoing partial parotidectomy
  • 20 ml of 0.5% bupivacaine (5 mg/mL), i.e., a dose of 100 mg;
  • 0.5 ml of dexamethasone (4 mg/mL), i.e., a dose of 2 mg.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Local pain post-injection
大体时间:Day 15
0-10 visual analog scale
Day 15
Local intolerance post-injection
大体时间:Day 15
Redness, edema, warmth, inflammation: Yes/no
Day 15
Local neurological disturbances post-injection
大体时间:Day 15
Paresthesia, hypoesthesia: Yes/no
Day 15
Allergic reactions post-injection
大体时间:Day 15
Rash, edema, urticaria: Yes/no
Day 15
Heart rate
大体时间:Day 15
beats per minutes
Day 15
Blood pressure
大体时间:Day 15
mm Hg
Day 15
Loss of consciousness
大体时间:Day 15
Yes/no
Day 15
Seizures
大体时间:Day 15
Yes/no
Day 15
Nausea and vomiting
大体时间:Day 15
Yes/no
Day 15
Blood gluose level
大体时间:Day 15
mmol/L
Day 15
Post-parotidectomy facial nerve function alteration post-injection
大体时间:Day 15
Facial paralysis or facial nerve damage: Yes/no
Day 15
Injection site damage
大体时间:Day 15
Hematoma or infection: Yes/no
Day 15

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain
大体时间:Day 0
Measure on a 0-10 visual analog scale
Day 0
Postoperative pain
大体时间:Day 1
Measure on a 0-10 visual analog scale
Day 1
Postoperative pain
大体时间:Day 2
Measure on a 0-10 visual analog scale
Day 2
Postoperative pain
大体时间:Day 4
Measure on a 0-10 visual analog scale
Day 4
Postoperative pain
大体时间:Day 6
Measure on a 0-10 visual analog scale
Day 6
Postoperative pain
大体时间:Day 9
Measure on a 0-10 visual analog scale
Day 9
Postoperative pain
大体时间:Day 12
Measure on a 0-10 visual analog scale
Day 12
Postoperative pain
大体时间:Day 15
Measure on a 0-10 visual analog scale
Day 15
Prevalence of salivary fistulas or sialomas
大体时间:Day 15
Yes/no
Day 15
wound dehiscence
大体时间:Day 15
yes/no
Day 15
inflammation of wound
大体时间:Day 15
Yes/no
Day 15
infection of wound
大体时间:Day 15
Yes/no
Day 15
Feasibility of bupivacaine/dexamethasone
大体时间:Day 0
Successful administion of bupivacaine/dexamethasone injection: Yes/no
Day 0

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Benjamin Lallemant、Centre Hospitalier Universitaire de Nîmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • LOCAL/2025/BL01
  • 2025 (美国 NIH 拨款/合同:Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524358-32-00 (其他标识符:CTIS)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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