Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
연구 개요
상세 설명
Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Cairo, 이집트, 11451
- Ahmed Abdalla Mohamed
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Physical status ASA II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.
Exclusion Criteria:
- Patient refusal.
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders and/or chronic pain.
- Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
- Significant liver or renal insufficiency.
- Localized infection at the site of block.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Paravertebral group (group P):
After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost.
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In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals. Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
다른 이름들:
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실험적: Control group (group C):
Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol).
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In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals. Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total intraoperative fentanyl consumption.
기간: 24 hours
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Total intraoperative fentanyl consumption.
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24 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.
기간: 24 hours
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Visual Analouge Scaleat 0 , 4 , 8 ,12 ,24 hours postoperatively.The VAS consists of a 10-cm line, with anchors at either end.
One end is marked "no pain" and the other end is marked "the worst imaginable pain".
The patient marks the place on the line to indicate his or her pain intensity.
The clinician then measures the line with a ruler and assigns a score.
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24 hours
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Heart rate and mean arterial blood pressure .
기간: 24 hours
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Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)
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24 hours
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Morphine consumption postoperatively for 24 hours..
기간: 24 hours Postoperative
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Morphine consumption per mg postoperatively for 24 hours..
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24 hours Postoperative
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Enas Mohamed Samir, M.D, Cairo University
- 연구 책임자: Walaa Y Elsabeeny, M.D, National Cancer Institute, Cairo 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
- MS-270-2019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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