Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
Perineural Dexmedetomidine vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 4단계
연락처 및 위치
연구 장소
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Wielkopolska
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Poznan, Wielkopolska, 폴란드, 61-545
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- children scheduled for foot/ankle surgery
- body weight > 5kg
Exclusion Criteria:
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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위약 비교기: Sham Block
0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
다른 이름들:
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활성 비교기: Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
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활성 비교기: Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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time to the first need of opiate following the procedure
기간: within 48 hours
|
Time after surgery when the patient needs opiate for the first time |
within 48 hours
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 4 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
4 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 6 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
6 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 8 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
8 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 12 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
12 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 16 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
16 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 20 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
20 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 24 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
24 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 36 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
36 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
기간: 48 hours
|
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. |
48 hours
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|
Neutrophil-to-lymphocyte ratio
기간: 24 hours after surgery
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Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample. |
24 hours after surgery
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Platelet-to-lymphocyte ratio
기간: 48 hours after surgery
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The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
48 hours after surgery
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Platelet-to-lymphocyte ratio
기간: 24 hours after surgery
|
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. |
24 hours after surgery
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|
Time to mobilization
기간: within 48 hours
|
Time after surgery when the patient moves the toe for the first time |
within 48 hours
|
공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Tomasz Kotwicki, Prof dr hab, Poznan University of Medical Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 18/2023
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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