Transversus-Thorax-Muskel-Ebene-Block versus Pektoralinterkostaler-Faszien-Block für verbessertes Erholungsmanagement nach Herzchirurgie
Transversus-Thorax-Muskel-Ebenen-Block versus Pektoral-Interkostal-Faszien-Block für verbesserte Genesung nach Herzoperationen: Eine randomisierte kontrollierte Studie
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Asyut Governorate
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Asyut, Asyut Governorate, Ägypten, 71515
- Assiut University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Exclusion Criteria:
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
- Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
- Known hypersensitivity or a history of allergy to local anesthetics.
- Had severe major organ dysfunction.
- Left ventricular ejection fraction below 30%.
- Pregnancy or breastfeeding.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Group PIFB
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
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Experimental: Group TTPB
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
|
Schein-Komparator: Control Group
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total amount analgesic requirement
Zeitfenster: 24 hours postoperatively
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In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given. |
24 hours postoperatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Degree of pain
Zeitfenster: 24 hours postoperatively
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Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain). NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery. |
24 hours postoperatively
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The number of patients required rescue analgesia
Zeitfenster: 24 hours postoperatively
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The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation. |
24 hours postoperatively
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Postoperative nausea and vomiting (PONV)
Zeitfenster: 24 hours postoperatively
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The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once. |
24 hours postoperatively
|
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Time to extubation
Zeitfenster: 24 hours postoperatively
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After the operation, the time until the patient is extubated will be recorded. |
24 hours postoperatively
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Length of stay in the intensive care unit.
Zeitfenster: Average 7 days postoperatively
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The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days. Total duration of stay in ICU will be recorded. |
Average 7 days postoperatively
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Assessment of Delirium
Zeitfenster: 24 hours postoperatively
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Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. It will be evaluated 24 hrs after extubation. |
24 hours postoperatively
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Level of patient satisfaction
Zeitfenster: 24 hours postoperatively
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Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied). |
24 hours postoperatively
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Incidence of complications.
Zeitfenster: 7 days postoperatively
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Any complications-directly related to the block or the drug used in the block- will be recorded. Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock. |
7 days postoperatively
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 04-2026-300788
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-Sharing-Zeitrahmen
After the end of study for one year.
IPD-Sharing-Zugriffskriterien
The data will be available upon a reasonable request from the corresponding author.
Art der unterstützenden IPD-Freigabeinformationen
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