Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Midlothian
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Edinburgh、Midlothian、イギリス、EH16 4SA
- Department of Surgery, Royal Infirmary of Edinburgh
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Epidural
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
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実験的：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.
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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Length of time to reach criteria for discharge from hospital.
時間枠：This will be assessed twice daily until criteria for dicharge from hospital are met.
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This will be assessed twice daily until criteria for dicharge from hospital are met.
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二次結果の測定
結果測定 |
時間枠 |
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Pain scores, assessed using numerical rating score (0 to 10).
時間枠：Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
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Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
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Nausea and sedation scores, assessed using numerical rating score (0 to 3).
時間枠：Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
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Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
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Sleep disturbance, assessed using numerical rating score (0 to 10).
時間枠：Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
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Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
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Volume of intravenous fluids received in the first 48 hours following operation (ml).
時間枠：Data collected daily for first 48 hours following operation.
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Data collected daily for first 48 hours following operation.
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Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
時間枠：From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
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From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
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Time to return of bowel function (days).
時間枠：Assessed daily until return of bowel function.
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Assessed daily until return of bowel function.
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Length of time to meet criteria for discharge from the High Dependency Unit.
時間枠：Assessed twice daily until criteria for discharge from the High Dependency Unit met.
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Assessed twice daily until criteria for discharge from the High Dependency Unit met.
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Complications (General and Technical).
時間枠：Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
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Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
術後の痛みの臨床試験
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