Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor (PAROCAINE)
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
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名:Benjamin Lallemant
- 电话号码:04.66.68.36.85
- 邮箱:benjamin.lallemant@chu-nimes.fr
学习地点
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-
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Nîmes、法国、30000
- 招聘中
- Centre Hospitalier de Nimes
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接触:
- Anissa Megzari
- 电话号码:04.66.68.42.36
- 邮箱:drc@chu-nimes.fr
-
首席研究员:
- Benjamin Lallemant
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
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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
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|
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
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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
调查人员
- 首席研究员:Benjamin Lallemant、Centre Hospitalier Universitaire de Nîmes
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
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)
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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