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.
調査の概要
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前:Benjamin Lallemant
- 電話番号:04.66.68.36.85
- メール:benjamin.lallemant@chu-nimes.fr
研究場所
-
-
-
Nîmes、フランス、30000
- 募集
- Centre Hospitalier de Nimes
-
コンタクト:
- Anissa Megzari
- 電話番号:04.66.68.42.36
- メール:drc@chu-nimes.fr
-
主任研究者:
- Benjamin Lallemant
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Patients who undergoing partial parotidectomy
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|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Local pain post-injection
時間枠:Day 15
|
0-10 visual analog scale
|
Day 15
|
|
Local intolerance post-injection
時間枠:Day 15
|
Redness, edema, warmth, inflammation: Yes/no
|
Day 15
|
|
Local neurological disturbances post-injection
時間枠:Day 15
|
Paresthesia, hypoesthesia: Yes/no
|
Day 15
|
|
Allergic reactions post-injection
時間枠:Day 15
|
Rash, edema, urticaria: Yes/no
|
Day 15
|
|
Heart rate
時間枠:Day 15
|
beats per minutes
|
Day 15
|
|
Blood pressure
時間枠:Day 15
|
mm Hg
|
Day 15
|
|
Loss of consciousness
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
Seizures
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
Nausea and vomiting
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
Blood gluose level
時間枠:Day 15
|
mmol/L
|
Day 15
|
|
Post-parotidectomy facial nerve function alteration post-injection
時間枠:Day 15
|
Facial paralysis or facial nerve damage: Yes/no
|
Day 15
|
|
Injection site damage
時間枠:Day 15
|
Hematoma or infection: Yes/no
|
Day 15
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain
時間枠:Day 0
|
Measure on a 0-10 visual analog scale
|
Day 0
|
|
Postoperative pain
時間枠:Day 1
|
Measure on a 0-10 visual analog scale
|
Day 1
|
|
Postoperative pain
時間枠:Day 2
|
Measure on a 0-10 visual analog scale
|
Day 2
|
|
Postoperative pain
時間枠:Day 4
|
Measure on a 0-10 visual analog scale
|
Day 4
|
|
Postoperative pain
時間枠:Day 6
|
Measure on a 0-10 visual analog scale
|
Day 6
|
|
Postoperative pain
時間枠:Day 9
|
Measure on a 0-10 visual analog scale
|
Day 9
|
|
Postoperative pain
時間枠:Day 12
|
Measure on a 0-10 visual analog scale
|
Day 12
|
|
Postoperative pain
時間枠:Day 15
|
Measure on a 0-10 visual analog scale
|
Day 15
|
|
Prevalence of salivary fistulas or sialomas
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
wound dehiscence
時間枠:Day 15
|
yes/no
|
Day 15
|
|
inflammation of wound
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
infection of wound
時間枠:Day 15
|
Yes/no
|
Day 15
|
|
Feasibility of bupivacaine/dexamethasone
時間枠:Day 0
|
Successful administion of bupivacaine/dexamethasone injection: Yes/no
|
Day 0
|
協力者と研究者
捜査官
- 主任研究者:Benjamin Lallemant、Centre Hospitalier Universitaire de Nîmes
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LOCAL/2025/BL01
- 2025 (米国 NIH グラント/契約:Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524358-32-00 (その他の識別子:CTIS)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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