Study of QL Analgesic Response and Extent (SQUARE)
Anterior Versus Posterior Versus Lateral Quadratus Lumborum Block: a Randomized Control Trial in Healthy Volunteers
調査の概要
詳細な説明
Regional anesthesia techniques are widely employed to achieve sensory blockade of the abdominal wall. Among these, the epidural remains the most well-established approach, offering bilateral spread. However, its association with neuraxial complications has led to a decline in its clinical use. In contrast, fascial plane blocks, avoid neuraxial-related risks. The advent of ultrasound-guided blocks has sparked growing interest in novel fascial plane blocks, that can deliver multi-dermatomal with a lower rate of complications.
Three Quadratus Lumborum (QL) blocks are an example of these fascial plane blocks, commonly performed for abdominal and pelvic surgery. Despite their widespread clinical use, no prior studies have directly compared the three techniques in terms of their cutaneous distribution. Additionally, case reports note that lower extremity weakness can sometimes temporarily occur as a result of accidental spread to the lumbar plexus. Thus, this randomized, double-blinded trial aims to investigate the cutaneous distribution of these three blocks in healthy adult volunteers. Lastly, this study will assess the incidence and severity of lower extremity weakness that may occur with each technique. In addition, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the blocks. Theoretically, there may be a difference in the anatomical target for these blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, as the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and all blocks should be similarly safe.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Brian Mendelson, MD
- 電話番号：818-456-7040
- メール：brian.mendelson@duke.edu
参加基準
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
説明
Inclusion Criteria:
- Ability to provide written informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- ASA physical status 1 or 2
- Age ≥ 18 years
- Weight > 70kg
Exclusion Criteria:
- BMI > 35kg.m2
- Use of analgesics within 24 hours before the procedure
- History of thoracic trauma or surgery
- Abdominal deformities or abnormalities that may prevent proper block performance
- Abdominal tattoos in the area of block performance
- Systemic neuromuscular disease
- Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)
- Structures are unable to be visualized by ultrasound
- Pregnancy
- Other known health conditions that would affect the participant's ability to successfully complete the study
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Lateral Quadratus Lumborum block
Participants receive quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
|
実験的：Anterior Quadratus Lumborum Block
Participants receive anterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
|
実験的：Posterior Quadratus Lumborum Block
Participants receive posterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
|
For the anterior QL block, a curvilinear probe and nerve stimulator will be used.
Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle.
A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle.
Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed.
For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist.
Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen.
For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.
|
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 |
|---|---|---|
|
Number of participants with blocked areas as measured by skin temperature discrimination
時間枠：60 to 90 minutes post-block
|
Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.
|
60 to 90 minutes post-block
|
|
Number of participants with blocked areas as measured by mechanical discrimination
時間枠：60 to 90 minutes post-block
|
Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.
|
60 to 90 minutes post-block
|
|
Blocked area as measured by cutaneous distribution mapping
時間枠：60 to 90 minutes post-block
|
Mapping the blocked area (using the previous temperature and mechanical assessments, demarcating lines on the skin) to calculate the area blocked.
|
60 to 90 minutes post-block
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Skin temperature of the chest wall
時間枠：60 to 90 minutes post-block
|
Infrared camera will assess skin temperature of the chest wall.
|
60 to 90 minutes post-block
|
|
Blocked area as measured by nociceptive discrimination
時間枠：60 to 90 minutes post-block
|
Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.
|
60 to 90 minutes post-block
|
|
Lidocaine systemic absorption
時間枠：0, 30, 60, 120, and 240 minutes after lidocaine administration
|
Calculate lidocaine systemic absorption (Cmax).
|
0, 30, 60, 120, and 240 minutes after lidocaine administration
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with block-related Adverse Events
時間枠：End of study (2 days post blocks)
|
Any block-related adverse events will be recorded.
|
End of study (2 days post blocks)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Brian Mendelson, MD、Duke University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
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
- Pro00118381
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
米国で製造され、米国から輸出された製品。
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