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外傷性肋骨骨折におけるケタミンとリドカインの比較

2026年11月2日 更新者:Brittany Hoyte

外傷性肋骨骨折患者におけるマルチモーダル疼痛管理のためのケタミン注入とリドカイン注入の前向きランダム化単盲検試験

Rib fractures continue to be a common occurrence in trauma patients of all ages. Traumatic rib fractures can cause severe pain in patients and lead to shallow breathing and further complications such as the need for mechanical ventilation, hospital or ventilator associated pneumonia, atelectasis, and acute respiratory distress syndrome. Effective multimodal pain management is needed to optimize a patient's respiratory status and can also play a role in early mobility, less pulmonary complications, shorter ICU and hospital length of stay, and decreased mortality. Current multimodal pain management options include opioids, muscle relaxants, gabapentin, acetaminophen, nonsteroidal anti-inflammatory drugs, and various regional/neuraxial anesthesia techniques. Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of opioids. However, there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures. Therefore, the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures.

調査の概要

詳細な説明

Effective pain control plays a key role is optimizing a patient's respiratory status after suffering multiple rib fractures. Using multimodal pain management techniques and optimizing a patient's pain control regimen helps to minimize the complications associated with rib fractures, such as pneumonia and the need for mechanical ventilation. The benefit of using opioid-sparing options such as ketamine or lidocaine infusions would be to avoid the side effects associated with opioids, which include delirium, constipation, and depressed respiratory drive.

Ketamine and lidocaine infusions are both medications that have been used in numerous studies to effectively treat post-operative pain. Low dose ketamine infusions have also recently been shown to be a safe and effective adjunct option to help reduce pain scores and decrease opioid use in patients with traumatic rib fractures. Currently there is no published studies to assess lidocaine's effectiveness to reduce pain scores and opioid use in traumatic rib fracture patients. There is also only one study to date that has directly compared ketamine to lidocaine infusions for pain control. This study occurred in 60 patients undergoing elective nephrectomy and evaluated three 24-hour infusion groups: ketamine, lidocaine, or placebo. The primary outcome showed that both ketamine and lidocaine infusions significantly reduced 24-hour OME compared to placebo (33% ketamine, 42% lidocaine) and decreased overall pain scores.

This trial is a single center, prospective, randomized trial of adult patients with ≥ 3 traumatic rib fractures admitted to a Level 1 trauma center at Spectrum Health Butterworth Hospital. As part of the current rib fracture protocol all patients will receive the standard multimodal pain regimen at the investigator's institution, including acetaminophen, NSAIDS, muscle relaxants and gabapentin. Currently ketamine infusions and regional/neuraxial anesthesia techniques are added if the standard multimodal pain regimen is insufficient. Lidocaine infusions have also been used at the institution for post-surgical pain control to minimize opioid use. The objective of the study will be to compare ketamine versus lidocaine infusions on the effectiveness to optimize pain control as well as minimize the use of opioids in patients with traumatic rib fractures.

If consent is obtained the patient will be randomized 1:1 to receive either a ketamine or lidocaine infusion for pain control, along with standard of care, using a pre-designed randomization schedule. Patients must be enrolled within 16 hours of hospital admission and are expected to remain on the infusion for a minimum of 24 hours. The duration, titration, and stopping of study drug will be dependent on the progress of the patient's overall pain status and provider decision, with data being included for the study medication for up to 72 hours. If patients require surgery at any time the study medication will not be held unless signs of adverse events occur. Patients who are unable to remain on the study infusion or have a regional/neuraxial anesthetic placed before the 24-hour mark (decided based on the Trauma and Surgical Intensive Care Unit services) will be considered a screen fail and no data will be contributed to the study, however, the screen fail will be documented. If a patient is unable to remain on infusion or has a regional/neuraxial anesthetic placed ≥ 24 hours, their data will be included up until that point and analyzed. Adverse event and serious adverse events will be monitored throughout the entire study period, with continuous cardiac telemetry being required in both study groups and daily lidocaine levels drawn in the lidocaine group.

研究の種類

介入

入学 (実際)

61

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Michigan
      • Grand Rapids、Michigan、アメリカ、49503
        • Corewell Health West

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Adults ≥ 18 years old
  2. ≥ 3 traumatic blunt rib fractures
  3. Enrollment within 16 hours of being admitted to the hospital
  4. Patients whom in the investigator's clinical judgement, would require escalated pain control regiments in the future and would potentially benefit from participation in this study in terms of pain control.

Exclusion Criteria:

  1. Patients receiving any regional/neuraxial anesthetic techniques or ketamine infusion before randomization

  2. Adults with diminished decision-making capacity

  3. Adults of limited English proficiency/non-English speakers

  4. Prisoners

  5. Pregnant or breastfeeding women

  6. Patient admission weight greater than 120 kg

  7. Patients with any of the following medical history:

    1. Active delirium (as defined by Confusion Assessment Method)
    2. Dementia
    3. Psychosis
    4. Glaucoma
    5. Heart block (except with patients with a functioning artificial pacemaker)
    6. Congestive heart failure (ejection fraction <20% recorded in last year)
    7. Adams-Stokes syndrome
    8. Wolff-Parkinson-White Syndrome
  8. Patient is unable to communicate with staff for pain assessments at time of enrollment

  9. Most recent documented Glasgow Coma Score <15 at the time of study enrollment

  10. Severe bradycardia (heart rate <50 bpm based on last vital sign recorded at time of study enrollment)

  11. Sustained hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg for at least 3 sets of vital signs in a row prior to study enrollment)

  12. Any seizure suspected or identified during hospital admission

  13. Patient with active acute coronary syndrome obtained from admission problem list

  14. Patients with known hepatic disease or acute liver failure

    a. Acute liver failure on admission defined as either: i. International normalized ratio > 1.5, without being on home anticoagulation ii. Aspartate aminotransferase or Alanine aminotransferase greater than 120 IU/L (3 times upper limit of normal) b. Known hepatic disease defined as past medical history of Child Turcotte Pugh (Child's) score C

  15. Patients with a history of end-stage renal disease or admission creatinine clearance (CrCl) ≤30 ml/min

    a. CrCl will be based on Cockcroft-Gault equation from admission labs

  16. Use of antiarrhythmic medication therapy prior or during admission

    a. Amiodarone, sotalol, dofetilide, dronedarone, mexilitine

  17. Patients with a known allergy/sensitivity to lidocaine or ketamine, amide anesthetics, or components of the solution

  18. Patients who, in the investigator's opinion, should not be included in this study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
アクティブコンパレータ:Ketamine

Infusion initiation: 0.1 mg/kg/hr Max: 0.3 mg/kg/hr Recommended titration: 0.1 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order

Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Will receive titratable infusion.

他の名前:
  • ケタラル
アクティブコンパレータ:Lidocaine

Infusion initiation: 1 mg/kg/hr Max: 2 mg/kg/hr Recommended titration:0.25 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order

Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Will receive titratable infusion, will have daily lidocaine level labs drawn daily.

他の名前:
  • キシロカイン

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
Oral Morphine Equivalent - Opioid Usage
時間枠:0-24 hours post infusion

Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.

0-24 hours post infusion

二次結果の測定

結果測定
メジャーの説明
時間枠
Visual Analogue Numeric Pain Score
時間枠:0-24; 24-48; 48-72 hours post infusion

Visual Analogue Numeric Pain Score are recorded as a scale of 1-10, with 0 being no pain and 10 as worst imaginable pain. Patient will be asked their pain score every 6 hours.

0-24; 24-48; 48-72 hours post infusion
Oral Morphine Equivalent - Opioid Usage
時間枠:24-48; 48-72 hours post infusion

Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.

24-48; 48-72 hours post infusion
Respiratory Failure
時間枠:0-30 days post-infusion

Respiratory failure was defined by need for mechanical intubation

0-30 days post-infusion
Use of Regional/Neuraxial anesthesia
時間枠:0-30 days post infusion

Measure of regional/neuraxial anesthesia placement rates. Patient would need to be taken off study medication if decision made to place regional/neuraxial anesthetic.

0-30 days post infusion
Hospital Length of Stay
時間枠:Will capture retrospectively after patient's medical discharge

Total hospital length of stay up to 365 days

Will capture retrospectively after patient's medical discharge
Intensive Care Unit Length of stay
時間枠:Will capture retrospectively after patient's medical discharge

Total intensive care unit length of stay up to 365 days

Will capture retrospectively after patient's medical discharge
Incentive Spirometry
時間枠:0-24; 24-48; 48-72 hours post infusion

Measure of percent improvement in incentive spirometry level from baseline (before infusion). Incentive spirometry levels range from 0-4,000 mL.

0-24; 24-48; 48-72 hours post infusion
Adverse events
時間枠:0-72 hours post infusion

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

0-72 hours post infusion
In-Hospital mortality
時間枠:Will capture retrospectively after patient's medical discharge

Patient's death will be recorded if it occurs before discharge

Will capture retrospectively after patient's medical discharge

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年4月1日

一次修了 (実際)

2024年10月10日

研究の完了 (実際)

2026年7月12日

試験登録日

最初に提出

2021年2月22日

QC基準を満たした最初の提出物

2021年3月1日

最初の投稿 (実際)

2021年3月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

いいえ

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

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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