Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.
This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.
연구 개요
상세 설명
High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.
This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Warmian-masurian
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Olsztyn, Warmian-masurian, 폴란드, 11-041
- Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients with primary liver tumor (HCC)
- patient scheduled for an elective surgery
- tumor diameter) <5 cm two tumors <3cm
- Age >18 years
- Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)
Exclusion Criteria:
- ASA IV and V
- Thrombocytopenia (<40x10 ^ 9 / L)
- Severe cirrhosis (Child-Pugh C classification)
- History of psychiatric/cognitive disease
- Patients who do not give informed consent
- Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
- History of chronic pain, chronic opioid use (> 3 months)
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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실험적: group PVB
standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
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Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible.
After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance.
Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.
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활성 비교기: group BB
standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).
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Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effectiveness of PVB on pain intensity
기간: NRS during the procedure and 0,1,3,6,24 hours post surgery
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The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain). comparison of analgesic drug use in both groups |
NRS during the procedure and 0,1,3,6,24 hours post surgery
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Effectiveness of PVB on pain intensity
기간: 0,1,3,6,24 hours post surgery
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The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
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0,1,3,6,24 hours post surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patients' satisfaction
기간: 24 hours post surgery
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Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey
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24 hours post surgery
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Surgeon's satisfaction
기간: 0 h post surgery (immediately after surgery)
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Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction)
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0 h post surgery (immediately after surgery)
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공동 작업자 및 조사자
수사관
- 연구 의자: Ewa Mayzner-Zawadzka, PhD, University of Warmia and Mazury Faculty of Medicine (University Hospital)
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
- UWarmiaMazury-2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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