- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04947007
Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies
Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
연구 개요
상태
정황
상세 설명
The investigators research was designed as a single-center, prospective, randomized double-blind study.
After the approval of the Ethics Committee, the study will start and is aimed to be completed in 6 months. The patients consecutively undergoing shoulder arthroscopy surgery in Istanbul University Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Preoperative evaluation of the patients will include detailed history, demographic and clinical parameters including gender, age, indication for shoulder arthroscopy, creatinine, chronic disease history will be recorded. Patients will be taken to the operating room after premedication with 2 mg midazolam and 50 mg fentanyl.
Patients will be monitored for rhythm, blood oxygen and pressure in the operating room. Ultrasonography (USG) guided suprascapular and axillary block will be performed. Suprascapular and axillary block will be done for postoperative analgesia. After the block is done, general anesthesia will be applied. In this study there will be four groups with the control group included. For the first group 15cc+15cc , for the second group 10cc+10cc for the third group 5cc+5cc of local anesthetic will be injected. The fourth group will be sham control.
Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patients will be followed up for 48 hours postoperatively in routine practice. They will be observed for postoperative nausea and vomiting, first mobilisation time, lenght of hospital stay, analgesic consumption and surgent and patient satisfaction.
Before the study, it was determined that at least 132 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, statistical analysis will be performed with Statistical Package for the Social Sciences (SPSS). The investigators study does not contain any modifications other than the investigators daily routine practices.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Fatih
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Istanbul, Fatih, 칠면조, 34093
- Istanbul University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients scheduled for total shoulder arthroscopy surgery
- Patients with American Society of Anesthesiology (ASA) Class 1-3
Exclusion Criteria:
- Refusal of regional anesthesia
- Infection on the local anesthetic application area
- Patients with known coagulopathy
- Known allergy against local anesthetics
- Anatomical difficulties to perform supra scapular and axillary blocks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
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In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
다른 이름들:
|
활성 비교기: Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
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In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
다른 이름들:
|
활성 비교기: Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
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In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
다른 이름들:
|
활성 비교기: Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
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In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Visual Analogue Scale (0-10) pain scores for patients
기간: 48 hours
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The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
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48 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Opioid (mg) consumption
기간: postoperative period up to 48th hours.
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Opioid (mg) consumption
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postoperative period up to 48th hours.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
수술 후 첫 동원까지의 시간
기간: 최대 48시간
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첫 동원 시간
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최대 48시간
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입원 기간
기간: 학습완료까지 평균 1주일
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입원
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학습완료까지 평균 1주일
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환자 만족도
기간: 수술 후 최대 48시간 및 수술 후 첫 달
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만족도 점수; 0- 매우 불만족, 3- 매우 만족
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수술 후 최대 48시간 및 수술 후 첫 달
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외과 의사 만족도
기간: 수술 후 최대 48시간 및 수술 후 첫 달
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만족도 점수; 0- 매우 불만족, 3- 매우 만족
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수술 후 최대 48시간 및 수술 후 첫 달
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Time of onset of narcotic analgesic need
기간: postoperative period up to 48th hours.
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(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
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postoperative period up to 48th hours.
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Incidence of side effects
기간: postoperative period up to 48th hour
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Incidence of nausea and vomiting
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postoperative period up to 48th hour
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nil R Kirsan, MD, Istanbul University
간행물 및 유용한 링크
일반 간행물
- Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
- Ozkan D, Cemaloglu S, Catma FM, Akkaya T. Effects of suprascapular and axillary nerve block on postoperative pain relief sevoflurane consumption and visual clarity in arthroscopic shoulder surgery. Agri. 2020 Jan;32(1):1-7. doi: 10.14744/agri.2019.04875.
- Price D. Optimizing the Combined Suprascapular and Axillary Nerve (SSAX) Block. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):122. doi: 10.1097/AAP.0000000000000518. No abstract available.
- Marty P, Rontes O, Delbos A. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Block: Interpret With Caution. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):273-274. doi: 10.1097/AAP.0000000000000551. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2020/1830
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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