- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01144273
Transversus Abdominis Plane Block From Abdominal Approach
Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
연구 개요
상태
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Kowloon
-
Kwun Tong, Kowloon, 홍콩
- 모병
- Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital
-
연락하다:
- Wing Yee Lillian Choy, MBBS (HK)
- 전화번호: 3513 4245
-
수석 연구원:
- Wing Yee Lillian Choy, MBBS (HK)
-
부수사관:
- Huey Sing Lim, FANZCA,FHKCA
-
부수사관:
- Man Shun Law, FHKCA,FHKAM
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ASA physical status I-III
- Age 18 or above
- Scheduled to undergo TAH+/- salpingoophorectomy.
- Scheduled to receive general anaesthesia under standardized anaesthetic regime.
- Comprehends how to use intravenous patient controlled analgesia (IV PCA).
- Is willing to complete the postoperative assessment.
- Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.
Exclusion Criteria:
- Known allergy to drugs involved in this study
- Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
- Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
- With co-existing pathology resulting in persistent pain requiring analgesics.
- Wound incision extending to supra-umbilical level.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 0.5% Ropivacaine
group receiving TAP block (0.5% ropivacaine at TAP plane)
|
This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
다른 이름들:
|
|
위약 비교기: normal saline
group receiving placebo (saline) at TAP plane
|
This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postoperative 24hr morphine consumption
기간: 24 hours
|
The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.
|
24 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
기간: 24hrs
|
• Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
|
24hrs
|
|
Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough
기간: 24hrs
|
24hrs
|
|
|
incidence of nausea and vomiting
기간: 24hours postoperatively
|
24hours postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Wing Yee Lillian Choy, MBBS (HK), United Christian Hospital, Hospital Authority
간행물 및 유용한 링크
일반 간행물
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Protocol ver 1.1
- KC/KE-10-0021/FR-3 (기타 식별자: Research Ethics committee (Kowloon Central/Kowloon East))
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. .