このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures

2026年8月4日 更新者:Sunnybrook Health Sciences Centre

Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures: a Single Centre, Randomized Controlled Trial

Rib fractures happen in about 10-20% of patients with blunt trauma and can be serious, with higher death rates in older adults. These injuries often lead to lung problems like pneumonia, collapsed lung areas (atelectasis), fluid buildup, or even respiratory failure. A major reason for this is pain-patients avoid deep breathing and coughing, which worsens lung function. Good pain control helps prevent these complications.

Opioids are commonly used for pain but can cause problems such as slowed breathing, delirium, nausea, and longer time on a ventilator. Because of this, regional anesthesia (nerve blocks) is increasingly used to control pain while reducing opioid use. Common options include epidurals, paravertebral blocks, and newer techniques like erector spinae plane (ESP) and serratus anterior plane (SAP) blocks. Continuous catheter techniques are especially useful in trauma patients because they can provide ongoing pain relief and have fewer contraindications than epidurals.

The SAP block is done at the side of the chest and works well for rib fractures in the front and side. It may not work as well for fractures in the back, although trauma may sometimes allow the anesthetic to spread further than expected.

The ESP block is done near the spine and may cover a broader area, including both front and back of the chest. It is relatively easy to perform at the bedside and is considered safe. Studies suggest it provides pain relief similar to epidurals in some patients.

There is still limited evidence directly comparing continuous SAP and ESP catheters. Only one study (using single injections) suggests ESP may provide better pain relief. It is unclear whether that difference holds true with continuous infusions, or whether SAP might be preferable because it is easier and quicker to perform.

We propose a randomized trial comparing continuous ESP and SAP catheters in patients with rib fractures to determine which provides better pain control, reduces opioid use, improves breathing outcomes, and is easier to perform in routine practice.

Our hypotheses are that ESP will provide better pain relief, SAP will be easier and safer to place, and both techniques will reduce opioid use while maintaining good patient comfort and breathing.

調査の概要

詳細な説明

Traumatic rib fractures occur in 10%-20% of blunt trauma patients and are associated with significant mortality (22% and 10%, in the elderly and young patients, respectively). Patients with rib fractures are predisposed to multiple pulmonary complications including pneumonia, aspiration, pleural effusion, pulmonary embolism, atelectasis and acute respiratory distress syndrome. Effective analgesia, albeit challenging, has been found to reduce the incidence of those complications. It is postulated that pulmonary complications occur post rib fractures due to impaired pulmonary mechanics, inappropriate clearance of secretions, and atelectasis; hence the need for adequate and affective pain control.

Opioids are commonly used for analgesia in critically ill patients but they carry notable adverse effects including: respiratory depression, hemodynamic instability, tolerance, hyperalgesia, delirium and gastrointestinal side effects. They are also associated with prolonged mechanical ventilation, counteracting goals for rib fracture management. Therefore, alternative analgesic option such as regional anesthesia techniques have gained more popularity. Regional anesthetic blocks can improve analgesia and reduce opioid requirements. Options for rib fractures include thoracic epidural analgesia (TEA), paravertebral block, intercostal block, erector spinae plane block (ESP), and serratus anterior plane block (SAP).

Continuous peripheral nerve blockage has gained more popularity in trauma settings; especially continuous fascial plane catheters which can offer effective analgesia without many contraindications associated with thoracic epidurals. Frequent contraindications to thoracic epidural blocks in trauma populations have driven interest in alternative analgesic modalities such as continuous fascial plane infusions, despite the lower pneumonia rates that are associated with thoracic epidural analgesia.

Serratus Anterior Plane Block (SAP Block): The SAP block is an ultrasound guided block that involves the injection of local anesthetic superficial to the serratus anterior muscle in the mid axillary line. It provides effective analgesia for patients with anterolateral rib fractures but might be ineffective for posterior rib fractures. It consistently involves the lateral cutaneous branches of intercostal nerves, which innervate the superficial anterolateral chest wall. It might spare the intercostal nerves supplying the posterior ribs and intercostal muscles. However, a cadaveric study showed that disruption of tissue planes in trauma may promote deeper spread of local anesthetic reaching the intercostal nerves and reaching the posterior rib space.

Erector Spinae Plane Block (ESP Block): The ESP block is an ultrasound guided block which involves injection of local anesthetic into the erector spinae fascial plane. It is thought to work by blocking the lateral cutaneous and intercostal nerves with potential diffusion into the paravertebral space. It is technically easy and can be performed at bedside. Risks are low, particularly when performed under ultrasound guidance, and include hypotension, vascular puncture, contralateral spread via the epidural space, and pneumothorax. A continuous nerve catheter is typically used for rib fractures with the goal of inserting the needle midpoint of the rib levels. A randomized trial has showed that continuous ESP block is as effective is thoracic epidural analgesia for pain control in patients with unilateral rib fractures.

Addressing evidence gaps: A recent scoping review published by our research group indicated that SAP and ESP are the most common regional anesthesia techniques for acute traumatic rib fractures. There has been one head-to-head study comparing SAP to ESP that demonstrated superior analgesia in favour of ESP for traumatic rib fractures however it was designed as a single injection study. Given that the SAP catheter is potentially easier to perform (i.e., no need to place patient in lateral decubitus position and shallower sonographic target), is ESP superior to SAP catheter infusion to warrant the additional time and effort? To our best knowledge, no prospective comparative studies on SAP and ESP catheters have directly evaluated analgesic efficacy, opioid consumption, respiratory outcomes, and ease of performance between these two catheter techniques in a systematic manner. Understanding which technique provides superior analgesia while remaining technically straightforward for widespread implementation is critical for standardizing regional anesthesia practice in rib fracture management. We propose a pragmatic, randomized controlled trial (RCT) comparing ESP and SAP to identify the best regional anesthesia catheter technique regardless of the pattern of rib fracture (anterior vs. posterior) and to allow adoption of a single technique to facilitate streamlined care. This knowledge gap represents an important opportunity to advance our understanding of the two established techniques in this trauma population.

研究の種類

介入

入学 (推定)

66

段階

  • 適用できない

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4N 3M5
        • Sunnybrook Health Sciences Centre
        • コンタクト:
        • 主任研究者:
          • Howard Meng, MD

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age >18;
  • Traumatic rib fractures (unilateral or bilateral);
  • Minimum of 3 rib fractures per side;
  • Admitted to hospital for <72 hours
  • NRS pain score > 4 at rest or with movement for chest pain at the time of eligibility assessment

Exclusion Criteria:

  • Severe traumatic brain injury (Glasgow Coma Scale < 9);
  • Surgery performed/planned within 72 hours of catheter infusion start;
  • Uncontrolled coagulopathy;
  • Skin infection or anatomical abnormality (i.e. open fracture) at insertion sites;
  • Allergy to local anesthetic;
  • Chronic high dose opioid use preadmission (Morphine Equivalent Dose > 30mg per day);
  • Pregnancy;
  • Acute respiratory failure requiring intubation at enrolment;
  • Inability to comply with Intravenous Patient-Controlled Analgesia use;
  • Contraindications to nerve blocks
  • High likelihood of loss to follow-up

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:Erector spinae plane catheter
Participants receive erector spinae plane catheter
Participants receive erector spinae plane catheter infusion
実験的:Serratus plane catheter
Participants receive serratus anterior plane catheter
Participants receive serratus plane catheter infusion

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
Pain with movement
時間枠:72 hours
Pain Numerical Rating Scale scores with movement from baseline through 72 hours post-placement. Numerical Rating Scale minimum is 0, maximum is 10, higher score = worse pain.
72 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Total opioid consumption
時間枠:72 hours
Total opioid consumption (IV and oral) between the SAP and ESP groups at 24, 48, and 72 hours post-catheter placement
72 hours
Respiratory function
時間枠:72 hours
forced expiratory volume in 1 second (FEV1), FEV1% of predicted, forced vital capacity (FVC), and peak inspiratory and expiratory flow will be measured using portable spirometry at baseline, 24 (± 4 hours), 48 (± 6 hours), and 72 (± 6 hours) hours post-catheter placement
72 hours
Ease of catheter insertion between techniques
時間枠:At time of catheter insertion
Number of skin puncture attempts
At time of catheter insertion
Pain at rest
時間枠:72 hours
Pain Numerical Rating Scale scores at rest from baseline through 72 hours post-placement. Numerical Rating Scale minimum is 0, maximum is 10, higher score = worse pain.
72 hours
Procedure related complications
時間枠:72 hours
Procedural complications (vascular puncture, local anesthetic toxicity signs, pneumothorax, infection at insertion site).
72 hours
Duration of catheter insertion procedure
時間枠:At the time of catheter insertion
Time from patient positioning to final catheter insertion and confirmation (in minutes)
At the time of catheter insertion

その他の成果指標

結果測定
メジャーの説明
時間枠
Patient satisfaction
時間枠:72 hours
Patient satisfaction scores using Patient Global Impression of Change (PGIC)
72 hours
Catheter-related complications
時間枠:72 hours
Catheter-related complications including infection, dislodgement, local anesthetic toxicity, and pneumothorax within the 72 hour study period
72 hours
Catheter function
時間枠:Through hospital admission, an average of 7 days
Duration of catheter function (days of infusion)
Through hospital admission, an average of 7 days
Hospital length of stay
時間枠:Duration of hospital admission, an average of 7 days
Total hospital length of stay (measured in days)
Duration of hospital admission, an average of 7 days
Intensive care stay
時間枠:Through hospital admission, an average of 7 days
Duration of intensive care stay
Through hospital admission, an average of 7 days
Pulmonary complications
時間枠:Through hospital admission, an average of 7 days
Documented pneumonia, ARDS, need for mechanical ventilation
Through hospital admission, an average of 7 days

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。

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 (推定)

2026年8月1日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2028年6月30日

試験登録日

最初に提出

2026年7月3日

QC基準を満たした最初の提出物

2026年8月4日

最初の投稿 (実際)

2026年8月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月10日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年6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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する