乳がん手術におけるリドカイン注入による持続性疼痛の予防 (PLAN)
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
調査の概要
詳細な説明
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alberta
-
Calgary、Alberta、カナダ
- Foothills Medical Centre
-
Edmonton、Alberta、カナダ
- Sturgeon Community Hospital
-
-
Newfoundland and Labrador
-
St. John's、Newfoundland and Labrador、カナダ
- Eastern Health- Health Sciences Centre
-
-
Nova Scotia
-
Halifax、Nova Scotia、カナダ
- IWK
-
-
Ontario
-
Hamilton、Ontario、カナダ
- Juravinski Hospital
-
North York、Ontario、カナダ
- North York General Hospital
-
Ottawa、Ontario、カナダ
- The Ottawa Hospital
-
Thunder Bay、Ontario、カナダ
- Thunder Bay Regional Health Sciences Centre
-
Toronto、Ontario、カナダ
- Mount Sinai Hospital
-
Toronto、Ontario、カナダ
- Humber River Hospital
-
Toronto、Ontario、カナダ
- St. Michael's Hospital
-
Toronto、Ontario、カナダ
- Sunnybrook Health Sciences Centre
-
Toronto、Ontario、カナダ
- University Health Network
-
Toronto、Ontario、カナダ
- Women's College Hospital
-
-
Quebec
-
Montreal、Quebec、カナダ
- Hôpital Maisonneuve-Rosemont
-
-
-
-
-
Ile-Ife、ナイジェリア
- Obafemi Awolowo University Teaching Hospitals Complex
-
-
-
-
-
Dharān、ネパール
- B.P. Koirala Institute of Health Sciences
-
-
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:
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Exclusion Criteria:
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
- Known cirrhotic liver disease
- Pregnant
- Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Intraoperative intravenous lidocaine/placebo infusion |
Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
他の名前：
|
|
プラセボコンパレーター：Control
Intraoperative intravenous lidocaine/placebo infusion |
Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).
他の名前：
|
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 |
|---|---|---|
|
Development of persistent pain 3-months after breast cancer surgery
時間枠：3- months
|
Persistent pain at 3-months |
3- months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensities
時間枠：3 and 12 months
|
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement. |
3 and 12 months
|
|
Opioid consumption
時間枠：3 and 12 months
|
Morphine-equivalent opioid consumption |
3 and 12 months
|
|
Moderate-to-severe persistent pain
時間枠：3 and 12 months
|
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours |
3 and 12 months
|
|
Persistent neuropathic pain
時間枠：3 and 12 months
|
Measured using the Douleur Neuropathique 4-symptoms interview |
3 and 12 months
|
|
Sensory and affective qualities of pain
時間枠：3 and 12 months
|
Quality of pain is reported using the Short Form McGill Pain Questionnaire |
3 and 12 months
|
|
Emotional functioning
時間枠：3 and 12 months
|
Emotional functioning is reported using the Profile of Mood States (POMS) |
3 and 12 months
|
|
Physical functioning
時間枠：3 and 12 months
|
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form. |
3 and 12 months
|
|
Health-related quality of life quality of life
時間枠：3 and 12 months
|
Health-related quality of life will be assessed using EQ-5D-5L |
3 and 12 months
|
|
Cancer Recurrence
時間枠：3 and 12 months
|
Cancer recurrence will be assessed as a secondary outcome |
3 and 12 months
|
|
Adverse events
時間枠：3 and 12 months
|
Adverse Events will be monitored as a secondary safety outcome |
3 and 12 months
|
|
Cost Effectiveness
時間枠：3 months
|
Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed |
3 months
|
協力者と研究者
捜査官
- 主任研究者：James Khan, MD、University Health Network, Toronto
- 主任研究者：PJ Devereaux, MD.PhD、Population Health Research Institute
- 主任研究者：Ian Gilron, MD、Kingston Health Sciences Centre
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 (推定)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 21-5021
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。