이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)

2015년 3월 12일 업데이트: Erica Revie, University of Edinburgh

The Effects of Local Infiltration Versus Epidural on Recovery

The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.

Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.

Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.

An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.

It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.

In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.

Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.

연구 개요

연구 유형

중재적

등록 (실제)

65

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Midlothian
      • Edinburgh, Midlothian, 영국, EH16 4SA
        • Department of Surgery, Royal Infirmary of Edinburgh

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients undergoing open hepatic resection for benign or malignant conditions.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women.
  • BMI 18-40.

Exclusion Criteria:

  • Patients with contraindication to either epidural or wound catheter techniques.
  • Inability to give written, informed consent.
  • Patients with dementia or neurological impairment.
  • Patients with pre-existing condition limiting mobility.
  • Underlying cirrhotic liver disease.
  • Jaundice (Bilirubin > 50 μmol/L).
  • Liver resection combined with secondary surgical procedure.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Epidural
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
  • Epidural analgesia for the first 48 hours postoperatively.
  • Sham wound catheter attached to anterior abdominal wall, for purposes of blinding.
  • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
  • Optimised recovery protocol followed throughout.
실험적: Wound catheter
Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia.
  • Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively.
  • Additional patient-controlled intravenous opiate analgesia available to patient during this time period.
  • Sham epidural catheter applied to the patient's back for purposes of blinding.
  • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
  • Optimised recovery protocol followed throughout.
다른 이름들:
  • ON-Q PainBuster

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Length of time to reach criteria for discharge from hospital.
기간: This will be assessed twice daily until criteria for dicharge from hospital are met.
This will be assessed twice daily until criteria for dicharge from hospital are met.

2차 결과 측정

결과 측정
기간
Pain scores, assessed using numerical rating score (0 to 10).
기간: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
기간: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Sleep disturbance, assessed using numerical rating score (0 to 10).
기간: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Volume of intravenous fluids received in the first 48 hours following operation (ml).
기간: Data collected daily for first 48 hours following operation.
Data collected daily for first 48 hours following operation.
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
기간: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
Time to return of bowel function (days).
기간: Assessed daily until return of bowel function.
Assessed daily until return of bowel function.
Length of time to meet criteria for discharge from the High Dependency Unit.
기간: Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Complications (General and Technical).
기간: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

수사관

  • 수석 연구원: Erica J Revie, University of Edinburgh

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 7월 1일

기본 완료 (실제)

2010년 7월 1일

연구 완료 (실제)

2010년 7월 1일

연구 등록 날짜

최초 제출

2010년 1월 4일

QC 기준을 충족하는 최초 제출

2010년 1월 4일

처음 게시됨 (추정)

2010년 1월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 3월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 3월 12일

마지막으로 확인됨

2015년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 09/S1102/17
  • 2009/R/SU/04 (기타 식별자: South East Scotland Research Ethics Committee 02)

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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