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

6. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

56

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Zeytinburnu
      • Istanbul, Zeytinburnu, Türkei (türkiye), 34010
        • Koc University Hospital
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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
Kein Eingriff: Control group
No superficial parasternal catheter will be placed

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at the first 72 hours after surgery
at the first 72 hours after surgery
Time to first rescue analgesic administration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: for 72 hours after surgery
for 72 hours after surgery
Postoperative Nausea and Vomiting
Zeitfenster: for 72 hours after surgery
for 72 hours after surgery
Time to first bowel movement
Zeitfenster: for 72 hours after surgery
Postoperative time to first bowel movement (defecation or flattus)
for 72 hours after surgery
Postoperative arrhythmia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. August 2026

Primärer Abschluss (Geschätzt)

30. Oktober 2026

Studienabschluss (Geschätzt)

15. November 2026

Studienanmeldedaten

Zuerst eingereicht

31. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. August 2026

Zuerst gepostet (Tatsächlich)

12. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Anonymized patient data will be published in a public repository

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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