Continuous ESP Block in Patients Undergoing CABG Surgery.
Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.
연구 개요
상태
상세 설명
All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.
All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: JOAO ALBERTO PASTOR de OLIVEIRA, MD
- 전화번호: +5511991700431
- 이메일: joaoalbertopastor@yahoo.com.br
연구 장소
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São Paulo
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São Paulo, São Paulo, 브라질
- 모병
- InCor
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Consent to the free and informed consent term.
- Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
- Preserved left ventricular global function (LVEF > 50%).
Exclusion Criteria:
- Moderate or severe valvular dysfunction.
- Previous anterior sternotomy.
- Known allergy to the study drugs.
- Complications during catheter insertion or block placement.
- Pre-existing diagnosed chronic pain under treatment.
- Concomitant use of drugs with a long half-life (induction and anesthetic maintenance doses will be standardized; patients taking medications with a long half-life are excluded to prevent bias in outcome assessment).
- Concomitant administration of Magnesium Sulfate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: ESP Block Ropivacaine PCA group
Local anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump.
Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing.
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Bilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL).
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
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위약 비교기: ESP Block placebo PCA group
Group that will serve as a comparison for blockade with analgesia.
That is, this group had received a placebo solution.
Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side).
After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger.
|
Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.
Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total morphine consumption
기간: From surgery completion up to postoperative day 5
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Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record.
All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents
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From surgery completion up to postoperative day 5
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Chronic pain scores at 30 days
기간: 30 days after intervention.
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Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
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30 days after intervention.
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Chronic pain scores at 180 days
기간: 180 days after intervention.
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Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.
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180 days after intervention.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
- 29585120.1.0000.0068
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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