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Parasternal Intercostal Plane Catheter for Pain Control After CABG Surgery (PIP-PAIN)

2026年8月6日 更新者:Rafet Onur Gorgulu、Koc University Hospital

The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial

Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. This study investigates whether placing a catheter to deliver a local anesthetic to the superficial parasternal intercostal plane reduces pain following this type of heart surgery. Patients undergoing CABG via sternotomy will be randomly assigned to either the catheter-based analgesia group or the standard pain management group. The researchers will compare postoperative pain levels and analgesic medication requirements between the two groups to determine whether this technique improves postoperative pain control.

調査の概要

状態

まだ募集していません

詳細な説明

Patients undergoing coronary artery bypass surgery will be included. Patients will be divided into two groups: the block group, in which a bilateral superficial parasternal plexus catheter will be inserted, and the control group, in which no parasternal plexus block or catheter will be administered.

In the block group, the catheter placement will be performed after completion of the surgery and before the patient is transferred to the ICU, under ultrasound guidance (Venue Go, GE, L4-T12 high-frequency linear probe). The probe will be positioned transversely across the costal cartilage, parallel to the sternum, in a parasagittal orientation at the level of 3rd rib. A 5-cm Tuohy needle will be inserted 2 cm lateral to the midline and advanced between the pectoralis major and external intercostal muscles at the third parasternal intercostal space. Needle tip position will be confirmed by negative aspiration for blood or air, followed by injection of 20 mL of bupivacaine 0.2% into the parasternal plane. Correct needle position will be confirmed by visualization of local anesthetic spread and hydrodissection separating the pectoralis major from the ribs and external intercostal muscles. A catheter (Tuohy Ultra-360 18G, B. Braun Contiplex, 400 mm) will then be placed into the parasternal intercostal space. Catheter position will be confirmed by ultrasound visualization of spread of 10 mL saline, after which the catheter will be secured. The procedure will be performed bilaterally. Postoperatively, 20 mL of bupivacaine 0.2% will be administered by the clinician through each parasternal catheter at 12, 24, 36, 48, 60, and 72 hours. Catheters will be removed by the clinician at 72 hours. Catheter-related complications, including bleeding, infection, and dislocation, will be recorded.

In the control group, no parasternal plexus block or catheter will be placed.

Intraoperative anesthesia technique will be identical in both groups. All patients will be admitted to the ICU orotracheally intubated and will be extubated in the ICU rather than in the operating room.

Pain nurses will assess all patients every 12 hours for 72 hours postoperatively. At each visit, pain score will be recorded using the Visual Analog Scale, where 0 corresponds to no pain and 10 corresponds to worst pain, assessed both at rest and during movement. Postoperative opioid consumption will be monitored via a patient-controlled analgesia device. The Morphine PCA solution will be prepared at a concentration of 1 mg/mL, with no background infusion, a bolus dose of 1 mL, and a lockout interval of 15 minutes. Additional (rescue) opioid analgesic requirements will be recorded by pain monitoring nurses. Rescue analgesia in both groups will consist of tramadol 1 mg/kg administered intravenously.

Patients' heart rhythm will be monitored continuously via telemetry throughout their hospital stay. Atrial tachyarrhythmias, including atrial flutter and atrial fibrillation, will be recorded throughout the hospital stay. Nausea, vomiting, and constipation will be recorded for 72 hours postoperatively.

Patient satisfaction will be assessed using a 5-point Likert scale, where 1 corresponds to strongly not satisfied and 5 corresponds to strongly satisfied. Hospital length of stay, ICU length of stay, and time to extubation in the ICU will be recorded for both groups.

研究の種類

介入

入学 (推定)

56

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。

研究場所

    • Zeytinburnu
      • Istanbul、Zeytinburnu、トルコ(Türkiye)、34010
        • Koc University Hospital
        • コンタクト:
        • コンタクト:

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:

- Adult patients with coronary artery disease scheduled for coronary artery bypass graft surgery

Exclusion Criteria:

  • Under 18 years of age
  • ASA (American Society of Anesthesiologists) Class V patients
  • Non-elective emergency cases
  • Patient refusal to participate in the study
  • Language barrier
  • Patients who have previously undergone sternotomy
  • History of significant psychiatric disorders
  • Patients with known long-term opioid use
  • Patients with potential contraindications to nerve blocks (bleeding diathesis, infection, and allergy to local anesthetics)
  • Patients with an ejection fraction <40%
  • Patients with right ventricular systolic dysfunction (patients with TAPSE <1.8 cm)
  • Patients with a left atrial diameter >4 cm
  • Patients with severe valvular heart disease
  • Patients undergoing concomitant valvular heart surgery
  • Patients with a history of atrial flutter and/or atrial fibrillation

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:なし(オープンラベル)

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:Block group
Patiens receiving bilateral superficial parasternal catheter at the end of the surgery
Bilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance
介入なし:Control group
No superficial parasternal catheter will be placed

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
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
時間枠:Postoperative 24 hours
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
Postoperative 24 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
時間枠:at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Resting pain levels of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
at 12, 24, 36, 48, 60, and 72 hours post-Surgery
NRS pain scores associated with coughing at 12, 24, 36, 48, 60, and 72 hours post-Surgery
時間枠:at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Pain levels associated with cough of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Total amount of opioids consumed during the first 72 hours after surgery
時間枠:at the first 72 hours after surgery
at the first 72 hours after surgery
Time to first rescue analgesic administration
時間枠:The patient will be monitored for the first 72 hours after surgery.
The time when rescue analgesia is first administered during the postoperative recovery period
The patient will be monitored for the first 72 hours after surgery.
Time to extubation (in minutes) following admission to the postoperative intensive care unit
時間枠:From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
It will be recorded as postoperative minutes.
From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
Length of stay in the intensive care unit
時間枠:From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
Length of hospital stay
時間枠:From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
Assessment of Patient Satisfaction Using a numeric rating scale
時間枠:at the 72nd hour postoperatively
Patients will be asked "How satisfied are you with your pain treatment" at 72 hours after surgery. A numeric rating scale will be used where 0 point meaning not satisfied at all and 10 points meaning can not be satisfied more.
at the 72nd hour postoperatively
Bleeding associated with a peripheral block catheter
時間枠:for 72 hours after surgery
for 72 hours after surgery
Postoperative Nausea and Vomiting
時間枠:for 72 hours after surgery
for 72 hours after surgery
Time to first bowel movement
時間枠:for 72 hours after surgery
Postoperative time to first bowel movement (defecation or flattus)
for 72 hours after surgery
Postoperative arrhythmia
時間枠:During the first 72 hours after surgery
Patients will be monitored via telemetry during their discharge period.
During the first 72 hours after surgery
Postoperative catheter-site infection
時間枠:From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
Dislocation of the parasternal block catheter
時間枠:During the first 72 hours after surgery
After the catheter is placed using ultrasound, the catheter site will be verified with saline.
During the first 72 hours after surgery

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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30日

一次修了 (推定)

2026年10月30日

研究の完了 (推定)

2026年11月15日

試験登録日

最初に提出

2026年7月31日

QC基準を満たした最初の提出物

2026年8月6日

最初の投稿 (実際)

2026年8月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月12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6日

最終確認日

2026年8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?

はい

IPD プランの説明

Anonymized patient data will be published in a public repository

IPD 共有時間枠

Starting at the completion of the study (anticipated November 2026) with no end date

IPD 共有アクセス基準

Anonymized patient data will be open to be accessed by any researcher

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