- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03504371
The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Oesophageal Surgeries
The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Patients Having Transthoracic Oesophygeal Surgical Procedures
연구 개요
상세 설명
The patients will randomised into 2 groups. There are 2 groups of patients: TEA combined with GA or bilateral erector spinae block combined with G. In TEA group, patients will receive TEA, an epidural catheter will be placed at the T7-8 interspace after positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%. Anaesthesia will be standardised. A left-sided, double-lumen thoracostomy tube will be inserted and confirmed by bronchofiberoscopy. In the TEA group, an additional 4-5mL epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second group, patients will receive bilateral ESP block which will be performed as follows. The patient will be placed in a lateral position and a high-frequency linear ultrasound transducer (GE LOGIQe, Wauwatosa, Wisconsin) will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle (EchoStim; Benlan Inc, Oakville, Canada) will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way without changing the position of the patient to achieve sensory block T5-T10 .
Hemodynamics as heart rate, arterial blood pressure, central venous pressure and oxygen saturation will be monitored intraoperatively. The heart rate and arterial blood pressure will be maintained within 20% of the preoperative values.
At the end of the procedure, in both groups, anesthesia will be discontinued and neuromuscular blockade will be antagonized with neostigmine, intravenous (0.05 mg/kg) and atropine intravenous (0.03 mg/kg) at appropriate doses.
The patients will be transported postoperatively to the intensive care unit. if VAS > 5 , Patient-controlled analgesia using elastomeric pump will be established with IV doses of morphine in the erector group (basal rate about 0.5mg/h to 1 mg/h and bolus dose of 2 mg , 300 mL maximum dose) and epidural analgesia in the TEA group (top up doses of about 4 ml of bupivacaine 0.125% + morphine 20 μg/mL, bolus doses 2 mL to 3 mL, 300 ml maximum dose). The patients will be monitored in the postanaesthesia care unit (PACU)
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트, 11566
- Ain Shams U
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
36-65 years old oesophageal procedures ASA I,II
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Exclusion Criteria:
- cardiac dysfunction Renal or hepatic impairment patient refusal Immune disorders Allergy to local anesthetics neuromuscular disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: bilateral erector spinae block
The patient placed in a lateral position and ultrasound transducer placed 3 cm lateral to the T7 spinous process.
Three muscles will be identified: trapezius, rhomboid major, and erector spinae.
8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony shadows of the transverse processes.
20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side in the same way without changing the position of the patient to achieve sensory block T5-T10 .
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The patient placed in a lateral position and transducer placed in a longitudinal orientation 3 cm lateral to the T7 spinous process.
Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.
An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes.
20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way to achieve sensory block T5-T10 .
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가짜 비교기: Thoracic epidural anesthesia
an epidural catheter placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine will be injected followed by 5-6 ml of bupivacaine 0.25%
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patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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postoperative complications
기간: 24 h
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minor complications (hypotension, vomiting, urinary retention and catheter related complications) and major complications (mortality).
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24 h
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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length of hospital stay
기간: 15-17 days
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Recovery time from end of surgery till discharge from hospital
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15-17 days
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공동 작업자 및 조사자
수사관
- 연구 의자: Nahed Effat, Ain Shams University
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
기타 연구 ID 번호
- FMASU R19
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구 프로토콜
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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진통 효능에 대한 임상 시험
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LMU Klinikum완전한중증 근무력증 | 근긴장성 이영양증 | 봉입체 근염 | 안면견갑상완 근이영양증 | Falls Efficacy Scale International | 모스 가을 규모독일
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Azienda Socio Sanitaria Territoriale Ovest Milanese...완전한
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