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

6 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

56

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turchia (Türkiye), 34010
        • Koc University Hospital
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Nessun intervento: Control group
No superficial parasternal catheter will be placed

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
Lasso di tempo: Postoperative 24 hours
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
Postoperative 24 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: at the first 72 hours after surgery
at the first 72 hours after surgery
Time to first rescue analgesic administration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: for 72 hours after surgery
for 72 hours after surgery
Postoperative Nausea and Vomiting
Lasso di tempo: for 72 hours after surgery
for 72 hours after surgery
Time to first bowel movement
Lasso di tempo: for 72 hours after surgery
Postoperative time to first bowel movement (defecation or flattus)
for 72 hours after surgery
Postoperative arrhythmia
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 agosto 2026

Completamento primario (Stimato)

30 ottobre 2026

Completamento dello studio (Stimato)

15 novembre 2026

Date di iscrizione allo studio

Primo inviato

31 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 agosto 2026

Primo Inserito (Effettivo)

12 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Anonymized patient data will be published in a public repository

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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