- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01743794
Continuous Wound Infusion in Lumbar or Thoracic Surgery
Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.
Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
-
-
Rhone Alpes
-
Grenoble, Rhone Alpes, 프랑스, 38000
- University Hospital, Departement of Anesthesia and Intensive Care
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- adults
- > 18 years
- Physical status score I, II or III (American Society of Anesthesiologists)
- lumbar or thoracic spine surgery with arthrodesis through posterior only approach
- signed informed consent
- beneficiary of social security
Exclusion Criteria:
- vulnerable persons according to law
- scoliosis surgery
- local anesthetic allergia
- contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
- long term anti platelet aggregants
- inability to comply to protocol requirements
- psychiatric disorders or cognitive disabilities
- chronic pain or long term opioids consumption
- diabetes
- obesity (BMI > 30)
- pregnancy or lactation
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 |
|---|---|
|
실험적: ropivacaine 0.2%, wound infusion
|
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
|
|
위약 비교기: saline solution 0.9%, wound infusion
|
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
morphine consumption
기간: 48 hours after surgery
|
48 hours after surgery
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
number of patients in need of morphine in post surgery monitoring room
기간: 1 hour after surgery
|
1 hour after surgery
|
|
morphine consumption in post surgery monitoring room
기간: 1 hour post surgery
|
1 hour post surgery
|
|
consumption of morphine
기간: 72 hours after surgery
|
72 hours after surgery
|
|
global self appreciation of pain management
기간: at 72 hours
|
at 72 hours
|
|
Time required for post surgery functional recovery
기간: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
Adverse effects of morphine
기간: 72 hours after surgery
|
72 hours after surgery
|
|
hospitalization delay
기간: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
asked bolus divided by delivered bolus
기간: until 72 hours after surgery
|
until 72 hours after surgery
|
|
Score for pain intensity
기간: until 72 hours after surgery
|
until 72 hours after surgery
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1008
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