Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.
The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.
Improving professional practice and quality care
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Poitiers, 프랑스, 86021
- Service Anesthésie-Réanimation
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years
- Hospitalized for upper extremity surgery scheduled
- Having an axillary block anesthesia.
- Free subject, without subordination or guardianship
- Patients undergoing a social security system or benefiting through a third party
- Informed consent and signed by the patient after clear and honest information on the study
Exclusion Criteria:
- Age < 18 years
- Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
- Hypersensitivity to local anesthetics of the amide
- Congenital Methemoglobinemia
- Porphyrias
- Glucose-6-phosphate dehydrogenase
- Hypersensitivity to any component of Dexeryl ®
- Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
- Epilepsy uncontrolled by treatment
- Patients on anticoagulants
- Skin infection from the puncture site
- Patients with psychiatric disorders or dementia
- Cons-indication for infusion Isofundine ®:
- Severe congestive heart failure
- anuria
- oligoanuria
- Fluid retention
- hyperkalemia
- hypercalcemia
- Metabolic alkalosis
- Patients not receiving a social security system or not qualifying through a third party
- People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )
공부 계획
연구는 어떻게 설계됩니까?
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Lidocaine-Prilocaine 5%
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위약 비교기: Dexeryl
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
|---|---|
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Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
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The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
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evaluation pain
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- Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,
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satisfaction
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- Assessment of satisfaction of anesthetists
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success
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The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EMLAX 2012-001976-13
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