Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
調査の概要
詳細な説明
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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California
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Stanford、California、アメリカ、94305
- Stanford Hospital and Clinics
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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 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.
Exclusion Criteria:
Patients will be excluded from participation if they have one or more of the following conditions:
- Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- Leukopenia (white blood cell count < 2,000/ul)
- Thrombocytopenia (platelet count < 100,000/ul)
- Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Pregnant or breastfeeding
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:トリプル
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:Anakinra
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
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An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
他の名前:
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プラセボコンパレーター:Saline injection
Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
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An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
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 |
メジャーの説明 |
時間枠 |
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Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
時間枠:Up to 72 hours following surgery
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Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery.
Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1
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Up to 72 hours following 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 |
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Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
時間枠:Up to 72 hours following surgery
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Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study. PCA/IV: Patient controlled Analgesia/ Intravenous |
Up to 72 hours following surgery
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Post-operative Pain Intensity
時間枠:Up to 72 hours following surgery
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Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)
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Up to 72 hours following surgery
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Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
時間枠:Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Count of Participants With Venous Thrombosis After Surgery During Hospitalization
時間枠:Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Assess Rates of Wound Dehiscence
時間枠:Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Total Length of Hospital Stay
時間枠:Up to approximately 5 days maximum (admittance to discharge)
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Total length of hospital stay for patients enrolled in the study.
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Up to approximately 5 days maximum (admittance to discharge)
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Robert L Lobato, MD、Stanford U
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 (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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SU-10312011-8587
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?
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。
痛みの臨床試験
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Dexa Medica Group完了
Anakinraの臨床試験
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Mid and South Essex NHS Foundation TrustUniversity of East Anglia; National Institute for Health Research, United Kingdom; Anglia Ruskin... と他の協力者完了