Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia
The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.
An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.
This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).
We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Marburg, 독일, 35037
- University of Marburg Department of Anaesthesia And Intensive Care Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients with knee replacement therapy and general anaesthesia
- informed consent
- preoperative "timed up and go" test performable
Exclusion Criteria:
- emergency patients
- BMI > 40 kg/m2
- American Society of Anaesthesiologists physical status (ASA) 4-5
- severe chronic obstructive pulmonary disease (COPD)
- rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
- nerve injury of lumbosacral plexus
- coagulopathy with bleeding tendency
- not capable of speaking or understanding german or english
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Continuous Adductor Canal Block (CACB)
Continuous Adductor Canal block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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활성 비교기: Continuous Femoral Nerve Block (CFNB)
Continuous Femoral Nerve Block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine |
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed-Up and Go-test for mobility evaluation
기간: third postoperative day
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The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
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third postoperative day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Scores
기간: 6, 24, 48, 72 hours postoperative
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Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain
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6, 24, 48, 72 hours postoperative
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Quadriceps strength
기간: 6, 24, 28, 72 hours postoperative
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Numeric Scale (0-5)
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6, 24, 28, 72 hours postoperative
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Ropivacaine consumption (each catheter)
기간: 24, 48, 72 hours postoperative
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Measurement of the total amount
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24, 48, 72 hours postoperative
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CAS (Cumulated Ambulation Score)
기간: 24,48,72 hours postoperative
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Cumulated Ambulation Score is calculated with routine data.
Measurement for ambulation ability
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24,48,72 hours postoperative
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Mobility Score (MoSc)
기간: 24,48,72 hours postoperative
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Is calculated with routine data.
Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)
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24,48,72 hours postoperative
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Analgesic regimen
기간: preop and 0, 6 , 24, 48, 48 hours postoperative
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Documentation of analgesic prescriptions and rescue medications during postoperative course
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preop and 0, 6 , 24, 48, 48 hours postoperative
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공동 작업자 및 조사자
수사관
- 연구 책임자: Karolin Piechowiak, Dr, Dept. of Anesthesia And Intensiv Care Medicine University of Marburg
- 연구 책임자: Thorsten Steinfeldt, Prof Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
- 연구 책임자: Thomas Wiesmann, Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg
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
- AZ 06/13
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. .
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