- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07812259
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 초기 1단계
연락처 및 위치
연구 연락처
- 이름: Benjamin Lallemant
- 전화번호: 04.66.68.36.85
- 이메일: benjamin.lallemant@chu-nimes.fr
연구 장소
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Nîmes, 프랑스, 30000
- 모병
- Centre Hospitalier de Nimes
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연락하다:
- Anissa Megzari
- 전화번호: 04.66.68.42.36
- 이메일: drc@chu-nimes.fr
-
수석 연구원:
- Benjamin Lallemant
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Patients who undergoing partial parotidectomy
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|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Local pain post-injection
기간: Day 15
|
0-10 visual analog scale
|
Day 15
|
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Local intolerance post-injection
기간: Day 15
|
Redness, edema, warmth, inflammation: Yes/no
|
Day 15
|
|
Local neurological disturbances post-injection
기간: Day 15
|
Paresthesia, hypoesthesia: Yes/no
|
Day 15
|
|
Allergic reactions post-injection
기간: Day 15
|
Rash, edema, urticaria: Yes/no
|
Day 15
|
|
Heart rate
기간: Day 15
|
beats per minutes
|
Day 15
|
|
Blood pressure
기간: Day 15
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mm Hg
|
Day 15
|
|
Loss of consciousness
기간: Day 15
|
Yes/no
|
Day 15
|
|
Seizures
기간: Day 15
|
Yes/no
|
Day 15
|
|
Nausea and vomiting
기간: Day 15
|
Yes/no
|
Day 15
|
|
Blood gluose level
기간: Day 15
|
mmol/L
|
Day 15
|
|
Post-parotidectomy facial nerve function alteration post-injection
기간: Day 15
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Facial paralysis or facial nerve damage: Yes/no
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Day 15
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Injection site damage
기간: Day 15
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Hematoma or infection: Yes/no
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Day 15
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain
기간: Day 0
|
Measure on a 0-10 visual analog scale
|
Day 0
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Postoperative pain
기간: Day 1
|
Measure on a 0-10 visual analog scale
|
Day 1
|
|
Postoperative pain
기간: Day 2
|
Measure on a 0-10 visual analog scale
|
Day 2
|
|
Postoperative pain
기간: Day 4
|
Measure on a 0-10 visual analog scale
|
Day 4
|
|
Postoperative pain
기간: Day 6
|
Measure on a 0-10 visual analog scale
|
Day 6
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|
Postoperative pain
기간: Day 9
|
Measure on a 0-10 visual analog scale
|
Day 9
|
|
Postoperative pain
기간: Day 12
|
Measure on a 0-10 visual analog scale
|
Day 12
|
|
Postoperative pain
기간: Day 15
|
Measure on a 0-10 visual analog scale
|
Day 15
|
|
Prevalence of salivary fistulas or sialomas
기간: Day 15
|
Yes/no
|
Day 15
|
|
wound dehiscence
기간: Day 15
|
yes/no
|
Day 15
|
|
inflammation of wound
기간: Day 15
|
Yes/no
|
Day 15
|
|
infection of wound
기간: Day 15
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Yes/no
|
Day 15
|
|
Feasibility of bupivacaine/dexamethasone
기간: Day 0
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Successful administion of bupivacaine/dexamethasone injection: Yes/no
|
Day 0
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Benjamin Lallemant, Centre Hospitalier Universitaire de Nîmes
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LOCAL/2025/BL01
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524358-32-00 (기타 식별자: CTIS)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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