- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649460
Shoulder Anterior Capsule Block Combined With Supra Scapular Nerve Versus Interscalene Block as Sole Anesthesia in Shoulder Arthroscopy
Shoulder Anterior Capsule Block Combined With Suprascapular Nerve Block Versus Interscalene Block as a Sole Anesthetic Technique for Shoulder Arthroscopy
연구 개요
상태
상세 설명
Ultrasonographic peripheral nerve block has been a popular technique not only for pain management but also for surgical anesthesia especially in patients with comorbidities, avoiding complications associated with general anesthesia (airway-difficulties, hemodynamic instability, etc.) and ensuring excellent pain control, reducing peri-operative consumption of opioids and their side effects, and improving patient satisfaction.
Interscalene block (ISB) is the gold stander anesthetic technique for shoulder surgeries but hemi-diaphragmatic paralysis still problematic. The SHAC is the combination of two different blocks. The first block is the inter fascial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia, anterior to the subscapularis myotendinous junction. This inter fascial space, we can reach both the axillary nerve and the subscapular nerves, the lateral pectoral nerve, and the musculocutaneous nerve results in achieving adequate anesthesia and analgesia without phrenic nerve affection.
The present study will be conducted to compare of SHAC block combined with suprascapular nerve block and Interscalene block as an anesthetic option in shoulder arthroscopic surgery may allow adequate postoperative analgesia and decrease the overall opioid usage and enhanced patient recovery
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Sharqia Province
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Zagazig, Sharqia Province, 이집트
- Zagazig University Hospitals
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Written informed consent from patients.
- BMI less than or equal 30 kgm .
- Age 18-75 years old.
- ASA class I, II and III.
Exclusion Criteria:
- Allergy to local anesthetics.
- Infection at site of injection.
- Patients with coagulopathy.
- Physical and mental disease which could interfere with pain scores evaluation.
- pre-existing neuropathy of the operative limb.
- Pre-existing sever pulmonary diseases (obstructive or restrictive).
- Patients with distorted local anatomy.
Patients with chronic pain syndrom
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Group SHAC block
Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
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Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
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활성 비교기: Group IS block
Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by using Visual Analogue Scale (VAS)
기간: From start of surgery and for the 1st 24 hours postoperatively.
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Inter-operative VAS immediately after the block and every 5 minutes for 30 minutes and every 2 hours post-operatively for 24 hours while 0 indicates no pain and 10 the severest pain.
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From start of surgery and for the 1st 24 hours postoperatively.
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia
기간: 24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia.
Duration of postoperative analgesia (from the time of patient recovery till the time of rescue analgesia).
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24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
기간: 1st 24 hours postoperatively.
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
Total dose of morphine per mg used during the 1st 24 hours postoperatively.
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1st 24 hours postoperatively.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety of SHAC block by monitoring of complications eg. local anesthetic toxicity , hemodynamics instability, phrenic nerve affection, pneumothorax.
기간: From start of surgery and for the 1st 24 hours.
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Monitoring of complications like local anesthetic toxicity ( restlessness, irritability, confusion, convulsions and arrhythmias) hemodynamics instability, phrenic nerve affection ( diaphragmatic paralysis) , pneumothorax ( decrease in oxygen saturation monitoring, tachypnea, diminished air entry on affected side by auscultation).
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From start of surgery and for the 1st 24 hours.
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Patient satisfaction with the anesthesia and analgesia during and after surgery
기간: From start of surgery and for the 1st 24 hours postoperatively.
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Patient satisfaction was evaluated by using satisfaction score and patients were graded on a 5-point scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied, and assessed at 24 h post-operation
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From start of surgery and for the 1st 24 hours postoperatively.
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공동 작업자 및 조사자
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .