- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Zeytinburnu
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Istanbul, Zeytinburnu, Turquia (Türkiye), 34010
- Koc University Hospital
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Contato:
- Rafet Onur Görgülü, MD
- Número de telefone: +90 538 731 71 39
- E-mail: ronurgorgulu@gmail.com
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Contato:
- Muhammet Selman Söğüt, MD
- Número de telefone: +90 505 618 32 19
- E-mail: ssogut@kuh.ku.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Block group
Patiens receiving bilateral superficial parasternal catheter at the end of the surgery
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Bilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance
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Sem intervenção: Control group
No superficial parasternal catheter will be placed
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
Prazo: Postoperative 24 hours
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Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
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Postoperative 24 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Prazo: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
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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
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at 12, 24, 36, 48, 60, and 72 hours post-Surgery
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NRS pain scores associated with coughing at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Prazo: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
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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
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at 12, 24, 36, 48, 60, and 72 hours post-Surgery
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Total amount of opioids consumed during the first 72 hours after surgery
Prazo: at the first 72 hours after surgery
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at the first 72 hours after surgery
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Time to first rescue analgesic administration
Prazo: The patient will be monitored for the first 72 hours after surgery.
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The time when rescue analgesia is first administered during the postoperative recovery period
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The patient will be monitored for the first 72 hours after surgery.
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Time to extubation (in minutes) following admission to the postoperative intensive care unit
Prazo: From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
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It will be recorded as postoperative minutes.
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From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
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Length of stay in the intensive care unit
Prazo: From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
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From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
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Length of hospital stay
Prazo: From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
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From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
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Assessment of Patient Satisfaction Using a numeric rating scale
Prazo: at the 72nd hour postoperatively
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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.
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at the 72nd hour postoperatively
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Bleeding associated with a peripheral block catheter
Prazo: for 72 hours after surgery
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for 72 hours after surgery
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Postoperative Nausea and Vomiting
Prazo: for 72 hours after surgery
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for 72 hours after surgery
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Time to first bowel movement
Prazo: for 72 hours after surgery
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Postoperative time to first bowel movement (defecation or flattus)
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for 72 hours after surgery
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Postoperative arrhythmia
Prazo: During the first 72 hours after surgery
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Patients will be monitored via telemetry during their discharge period.
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During the first 72 hours after surgery
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Postoperative catheter-site infection
Prazo: From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
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From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
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Dislocation of the parasternal block catheter
Prazo: During the first 72 hours after surgery
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After the catheter is placed using ultrasound, the catheter site will be verified with saline.
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During the first 72 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026.216.IRB1.015
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