Remote Controlled Analgesia on Patient Experience (R-CAPE)
Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
調査の概要
詳細な説明
Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.
Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
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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Montpellier、フランス、34295
- Department of Anesthesiology and critical care, Lapeyronie University Hospital
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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:
- Male or female subject aged 18 or more, up to 80 years;
- Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
- Eligible to outpatient care;
Respecting the ambivalence clause defined below:
- no cons-indication to analgesic perineural catheter;
- not known allergy to local anesthetics;
- likely to be a candidate for continuous nerve block analgesia;
- Ability to complete a self-reported questionnaire;
- Have given written informed consent
Exclusion Criteria:
- Age less than 18 or more than 80 years;
- Pregnant or nursing women ;
- Not being affiliated to the social security scheme;
- Known allergy to local anesthetics of the amide type;
Regulatory constraints in the outpatient management of perineural catheters not respected:
- Inability of daily nursing care;
- No presence of a responsible adult at home the night of the intervention;
- Scheduled hospital stay;
- ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
- Spontaneous request for continuous nerve block or single injection;
- Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Topic treated with antipsychotics (neuroleptics or lithium);
- Subject has a documented chronic pain syndrome;
- Active consumer of narcotic topic;
- Topic have not signed informed consent.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Electronic pump
Continuous nerve blocks Remote-controlled perineural local anesthetics delivery
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Remote-controlled perineural local anesthetics delivery
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介入なし:single injection
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Patient experience and satisfaction scale (EVAN-G)
時間枠:Second day after surgery
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Description: Patient experience and satisfaction scale
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Second day after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Patient quality of recovery (QoR)
時間枠:First day after surgery
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Description: Patient quality of recovery
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First day after surgery
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協力者と研究者
捜査官
- スタディチェア:Xavier CAPDEVILA, M.D., Ph.D.、University Hospital, Montpellier
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 (実際)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- 9677
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個々の参加者データ (IPD) を共有する予定はありますか?
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