- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07759570
Parasternal Intercostal Plane Catheter for Pain Control After CABG Surgery (PIP-PAIN)
The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turquie (Türkiye), 34010
- Koc University Hospital
-
Contact:
- Rafet Onur Görgülü, MD
- Numéro de téléphone: +90 538 731 71 39
- E-mail: ronurgorgulu@gmail.com
-
Contact:
- Muhammet Selman Söğüt, MD
- Numéro de téléphone: +90 505 618 32 19
- E-mail: ssogut@kuh.ku.edu.tr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Aucune intervention: Control group
No superficial parasternal catheter will be placed
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
Délai: Postoperative 24 hours
|
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
|
Postoperative 24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Délai: 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
Délai: 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
Délai: at the first 72 hours after surgery
|
at the first 72 hours after surgery
|
|
|
Time to first rescue analgesic administration
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: for 72 hours after surgery
|
for 72 hours after surgery
|
|
|
Postoperative Nausea and Vomiting
Délai: for 72 hours after surgery
|
for 72 hours after surgery
|
|
|
Time to first bowel movement
Délai: for 72 hours after surgery
|
Postoperative time to first bowel movement (defecation or flattus)
|
for 72 hours after surgery
|
|
Postoperative arrhythmia
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026.216.IRB1.015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .