Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery
A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
연구 개요
상세 설명
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aarhus, 덴마크, 8000
- Aarhus University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: Elective major ankle surgery
- total ankle arthroplasty
- subtalar fusion
- ankle fusion (non arthroscopic)
Exclusion Criteria:
- coagulation abnormalities
- infection in the region of needle insertion
- systemic infection
- preoperative consumption of high dose opioid
- preoperative sciatic or femoral nerve neuropathy
- preoperative sensory deficit in either of the lower extremities
- Charcot-Marie-Tooth disorder
- diabetic neuropathy
- severe peripheral vascular disease
- allergy to local anesthetics
- lack of understanding of Numeric Rank Scale (NRS)
- communication problems
- dementia
- body mass index above 35
- bilateral continuous sciatic nerve block
- lack of consent
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 |
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활성 비교기: 0,2% Ropivacaine
Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
다른 이름들:
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위약 비교기: Control
Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Accumulated opioid consumption
기간: First 48 hours postoperative
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First 48 hours postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Success rate for saphenous nerve analgesia
기간: Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for clinical analgesia of foot and ankle
기간: Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for tibial and peroneal nerve block
기간: Postoperative, first 48 hours
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Pain rated by NRS and test of sensation on the toes
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Postoperative, first 48 hours
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Localisation of worst pain
기간: Postoperative, first 48 hours
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Postoperative, first 48 hours
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Cost-effectiveness
기간: 2 first postoperative days
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2 first postoperative days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas F Bendtsen, ph.d., MD, Aarhus University Hospital
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
- 2011-0184
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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