개흉술 후 수술 후 통증에 대한 초음파 유도 PIFB 대 리도카인 주입의 효능
급성 및 만성 개흉술 후 통증에 대한 초음파 유도 늑간근 근막 차단 대 리도카인 주입의 효능; 전향적 무작위 대조 시험
Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .
연구 개요
상태
정황
상세 설명
Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.
Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PSPS
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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e\EYGPT
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Banī Suwayf, e\EYGPT, 이집트
- Benisuef University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age between 18 and 75 years.
- patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- American Society of Anesthesiologists classification of physical status < IV.
Exclusion Criteria:
- emergency surgery.
- off-pump surgery.
- redo surgery.
- ejection fraction less than 35%.
- refusal of the patient.
- known hypersensitivity to LA.
- chronic opioid use or chronic pain patient.
- psychiatric problems or communication difficulties.
- liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
- renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
- obstructive sleep apnea syndrom.
- coexisting hematologic disorders.
- pregnancy or breastfeeding.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: PIFB group
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side. |
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.
다른 이름들:
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활성 비교기: LIDOCAINE group
1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery. |
1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total dose of morphine in the first 24 h postoperatively.
기간: 24 hours postoperative
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total morphine consumed in the first 24 hour |
24 hours postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NRS numerical rating scale.
기간: 24 hours post operative
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NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief |
24 hours post operative
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chronic postoperative pain in 3 months after operation according to numerical rating scale
기간: within 3 months postoperative
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NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief |
within 3 months postoperative
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Time to rescue analgesic
기간: within 24 hour postoperative
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time from extubation to the time the patiants given analgesia |
within 24 hour postoperative
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time to extubation
기간: within 24 hour post operative
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from end of surgery to the time of extubation |
within 24 hour post operative
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length of intensive care stay
기간: within one week
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from end of surgery to the time of discharging to the surgical word |
within one week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mariana A mansour, Lecturer, benisuef university hospital,Egypt
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. .