- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07622823
Fascial Plane Blocks In Cardiac Surgery
1. juni 2026 opdateret af: Antalya Health Sciences University
The Effect Of Combined Rectus-Intercostal Fascial Plane Block Or Rectus Sheatf Block With A Pectoral-Intercostal Fascial Plane Block In Cardiac Surgery On Postoperative Opioid Consumption, Quality Of Recovery, And Chronic Pain: A Prospective, Observational Study
The aim of the present study is to evaluate the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in patients undergoing cardiac surgery.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
Effective pain management after cardiac surgery is crucial in improving patient outcomes, promoting early postoperative mobilisation and minimising the risk of postoperative respiratory complications.
It has indeed been shown that these patients experience moderate to severe pain during the postoperative period.
While opioids are commonly used in perioperative care, they are also linked to adverse opioid-related effects.
The literature suggests selecting an analgesic treatment strategy that avoids opioid-based analgesia for patients undergoing cardiac surgery during the postoperative period.
Regional anaesthesia techniques are widely used in cardiac surgery patients to address concerns about the risk of myocardial and/or renal damage associated with non-steroidal anti-inflammatory drugs (NSAIDs), reduce the incidence of potential opioid-related side effects, lower the high risk of delirium and improve patient rehabilitation.
However, only a limited number of studies have demonstrated the effects of the recto-intercostal fascial plane block (RIFPB) or the rectus sheath block (RSB) combined with the pectoral-intercostal fascial plane block (PIFPB) on postoperative analgesia in cardiac surgery patients.
Therefore, the present study aims to evaluate the effects of the RIFPB or the RSB combined with the PIFPB on postoperative analgesia in patients undergoing cardiac surgery.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Arzu Karaveli
- Telefonnummer: +905325611300
- E-mail: arzukaraveli@hotmail.com
Studiesteder
-
-
-
Antalya, Tyrkiet (Türkiye)
- Rekruttering
- University of Health Sciences, Antalya Training and Research Hospital
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
It is planned to include ASA score I-IIII adult patients who are scheduled to elective cardiac surgery
Beskrivelse
Inclusion Criteria:
- elective cardiac surgery planned
- over 18 years, adult
- American Society of Anaesthesiology (ASA) score I-III
Exclusion Criteria:
- under 18 years of age,
- ASA IV and above,
- contraindications for the block application
- history of cardiac surgery,
- reoperated due to surgery-related complications after emergency surgery or postoperative elective surgery,
- off-pump cardiac surgery or minimally invasive cardiac surgery
- unable to be extubated in the intensive care unit at 24 hours postoperatively
- history of chronic pain treatment
- chronic alcoholism and substance abuse
- declining to give written informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Styring
|
Regional anesthesia is not applied.
|
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PIFPB+RIFPB
|
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
|
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PIFPB+RSB
|
The procedure is performed under ultrasound guidance in a separate regional anaesthesia room during the preoperative period, under standard ASA monitoring.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
postoperativt opioidforbrug
Tidsramme: 48 timer
|
48 timer
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative recovery quality
Tidsramme: 24 hours
|
TThe Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery.
This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period.
The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points.
|
24 hours
|
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postoperative pain scores
Tidsramme: 48 hours
|
The NRS score (0=no pain; 10=most severe pain) will be used to assess postoperative pain
|
48 hours
|
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chronic pain
Tidsramme: 3 months
|
Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally.
The NRS score (0=no pain; 10=most severe pain) will be used to assess postoperative pain.
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Arzu Karaveli, University of Health Sciences, Antalya Training and Research Hospital
- Ledende efterforsker: Ceren Nida Kural, University of Health Sciences, Antalya Training and Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.
- Grant MC, Gregory AJ, Ouanes JP. Regional analgesia for cardiac surgery. Curr Opin Anaesthesiol. 2022 Oct 1;35(5):605-612. doi: 10.1097/ACO.0000000000001169. Epub 2022 Jul 27.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
26. maj 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 7/20
Plan for individuelle deltagerdata (IPD)
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