Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
연구 개요
상태
정황
상세 설명
The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.
The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.
Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was >4, patients in both groups were administered diclofenac.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Adana, 칠면조, 01230
- Çukurova University Faculty of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 53 patients scheduled for percutaneous nephrolithotomy (PNL),
- 18-70 years of age,
- weight between 50-100 kg,
- American Society of Anesthesiologists (ASA) classification I-II were included
Exclusion Criteria:
- The exclusion criteria were refusals by patients,
- coagulation abnormalities,
- patients with spinal deformity,
- cutaneous infection at the injection site and
- a known allergy to drugs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group Paravertebral Block
With ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level.
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paravertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution. After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery.
After,patients in both groups were performed patient controlled analgesia (PCA).
The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline.
The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
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위약 비교기: Group tramadol
Patients in group T were given a loading dose of tramadol of 1 mgkg-1
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Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery.
After,patients in both groups were performed patient controlled analgesia (PCA).
The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline.
The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Analogue Scale
기간: up to 24 hours
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Postoperative pain degree was evaluated by Visual Analogue Scale
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up to 24 hours
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2차 결과 측정
결과 측정 |
기간 |
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tramadol consumption
기간: up to 24 hours
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up to 24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zehra Hatipoğlu, Assist Prof, Cukurova University
간행물 및 유용한 링크
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 (추정)
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
- 5/8-2012
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