Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty
Comparison of the Effects of iPACK Block Combined With Continuous Adductor Canal Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Total Knee Arthroplasty Cases
This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.
調査の概要
詳細な説明
Severe postoperative pain occurs in up to 58% of patients after total knee arthroplasty. Peripheral nerve blocks are an effective component of multimodal analgesia, and the continuous adductor canal block (CACB) has become a preferred technique because it provides sensory blockade while sparing motor function of the quadriceps, allowing earlier ambulation compared to femoral nerve block. However, CACB does not address posterior knee pain, which can be targeted by the iPACK (infiltration between the popliteal artery and capsule of the knee) block, a technique that blocks terminal sensory branches of the tibial and peroneal nerves without motor blockade.
In this study, patients scheduled for total knee arthroplasty will be randomized 1:1 (using randomizer.org) to receive either CACB alone (Group 2) or CACB combined with a single-injection iPACK block (Group 1). CACB will be maintained via a perineural catheter connected to a patient-controlled analgesia (PCA) pump delivering 0.1% bupivacaine. Rescue analgesia will be provided with intravenous tramadol (50 mg, max 300 mg/day) when the numeric rating scale (NRS) pain score exceeds 4.
Pain scores (NRS 0-10), total analgesic and opioid consumption, hemodynamic parameters, time to first mobilization (assessed via the Timed Up and Go test), patient satisfaction, and length of hospital stay will be recorded at baseline and at 1, 3, 6, 12, and 24 hours postoperatively by an anesthesiologist blinded to group allocation, different from the anesthesiologist who performed the block.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muzaffer GENCER, MD
- 電話番号：905059436459
- メール：dr.m.gencer07@gmail.com
研究連絡先のバックアップ
- 名前：Furkan TONTU, MD
- 電話番号：905465771656
- メール：furkantontu@gmail.com
研究場所
-
-
Istanbul
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Başakşehir、Istanbul、トルコ（Türkiye）、34480
- Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye
-
コンタクト：
- Muzaffer GENCER, MD
- 電話番号：905059436459
- メール：dr.m.gencer07@gmail.com
-
コンタクト：
- Murat Y MERSİN, MD
- 電話番号：905367736432
- メール：myasinmersin@gmail.com
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主任研究者：
- Furkan TONTU, MD
-
副調査官：
- Muzaffer GENCER, MD
-
副調査官：
- Murat Y Mersin, MD
-
-
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 of either sex
- Aged 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Voluntary participation
- Fully oriented and able to cooperate with postoperative assessments
Exclusion Criteria:
- ASA physical status IV or V
- Patients who decline to participate
- Pediatric patients
- Active infection at the block site
- Chronic pain or regular analgesic use
- Coagulation disorders
- Inability to cooperate with postoperative pain assessment
- Known allergy to local anesthetics
- Neuropathy or myopathy in the operated extremity
- Revision arthroplasty cases
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1 (CACB + iPACK)
Continuous adductor canal block (catheter, PCA with 0.1% bupivacaine) plus a single-injection iPACK block (0.25% bupivacaine 20 mL) |
Single injection of 0.25% bupivacaine 20 mL between the popliteal artery and posterior knee capsule, performed under ultrasound guidance Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
|
アクティブコンパレータ：Group 2 (CACB Alone)
Continuous adductor canal block alone (catheter, PCA with 0.1% bupivacaine) |
Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
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 |
|---|---|---|
|
Postoperative Pain Score (Numeric Rating Scale)
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable) |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
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：Postoperative 24 hours
|
Total rescue analgesic (tramadol) consumption via intravenous (IV) administration |
Postoperative 24 hours
|
|
Total Local Anesthetic Consumption
時間枠：Postoperative 24 hours
|
Total bupivacaine consumed via patient-controlled analgesia (PCA) pump |
Postoperative 24 hours
|
|
Time to First Mobilization
時間枠：Postoperative 24 hours
|
Time to first unassisted ambulation/movement, assessed via the Timed Up and Go (TUG) test |
Postoperative 24 hours
|
|
Length of Hospital Stay
時間枠：From surgery to discharge (up to approximately 1 week)
|
Number of days from surgery to discharge |
From surgery to discharge (up to approximately 1 week)
|
|
Patient Satisfaction Score
時間枠：Postoperative 24 hours
|
Satisfaction rated on a 4-point scale (1 = not satisfied, 2 = Slightly satisfied, 3 = Satisfied, 4 = very satisfied) |
Postoperative 24 hours
|
|
Systolic Blood Pressure
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Systolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Diastolic Blood Pressure
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Diastolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Mean Arterial Blood Pressure
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Mean arterial blood pressure (MAP) measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Heart Rate
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Heart rate measured in beats per minute |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Peripheral Oxygen Saturation
時間枠：Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Peripheral oxygen saturation (SpO2) measured as a percentage |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Block-Related Complications
時間枠：Throughout study participation (up to 24 hours postoperatively)
|
Incidence of complications associated with the regional block techniques (e.g., nerve injury, infection) |
Throughout study participation (up to 24 hours postoperatively)
|
協力者と研究者
捜査官
- 主任研究者：Furkan TONTU, MD、BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- スタディディレクター：Muzaffer GENCER, MD、BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- スタディディレクター：Murat Y Mersin, MD、BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİt
出版物と役立つリンク
一般刊行物
- Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
- Diz Protezi Ameliyatı Sonrası Sürekli Adduktör Kanal Bloğuna Popliteal Arter ve Diz Kapsülü Arası İnfiltrasyon Bloğunun (IPACK) Eklenmesinin Etkisi DOI: 10.1080/11101849.2023.2246732
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
その他の研究ID番号
- BSH-ANES-MYM-02
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?
IPD プランの説明
Individual participant data will not be shared beyond what is reported in publications resulting from this study.
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
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