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Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study

30. maj 2026 opdateret af: Mehmet Akif Yilmaz, Ataturk University

Determination of the Effect of Parasternal Block Versus Wound Site Infiltration on Postoperative Pain Levels by Salivary Opiorphin Levels in Patients Undergoing Median Sternotomy: A Randomized Prospective Study

This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy. Patients were allocated to receive parasternal block, wound site infiltration, or standard systemic analgesia. Salivary opiorphin levels and postoperative pain scores were assessed to compare analgesic effectiveness between the groups.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This randomized prospective study included patients undergoing surgery through median sternotomy. The study compared three perioperative analgesic approaches: parasternal block, wound site infiltration, and standard systemic analgesia without local intervention at the surgical site.

Salivary samples were collected before surgery, after sternotomy, and during the postoperative period to measure opiorphin levels. Postoperative pain was assessed using visual analogue scale scores, and additional analgesic requirement, opioid consumption, extubation time, intensive care unit stay, and adverse effects such as nausea and vomiting were recorded.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

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

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for surgery through median sternotomy
  • Patients who provided informed consent

Exclusion Criteria:

  • Age under 30 years
  • Presence of ischemic, inflammatory, or systemic disease, except cardiovascular disease
  • Use of analgesic medication within the last 24 hours
  • Diagnosis of psychiatric disorder
  • Presence of any oral pathology, including active dental caries, aphthous lesions, or salivary gland inflammation
  • Prolonged intubation or inability to be separated from mechanical ventilation for more than 8 hours

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Parasternal Block Group
Participants in this group received ultrasound-guided parasternal block with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia.
Procedure: Parasternal blocks
Ultrasound-guided parasternal block was performed with local anesthetic before surgical incision.
Aktiv komparator: Wound Site Infiltration Group
Participants in this group received wound site infiltration with local anesthetic before surgical incision, in addition to standard perioperative systemic analgesia.
Procedure: Wound Site Infiltration
Local anesthetic infiltration was performed at the surgical wound site before surgical incision.
Ingen indgriben: Standard Analgesia Group
Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Salivary Opiorphin Level
Tidsramme: Baseline, 3 minutes after sternotomy, and postoperative 6 hours
Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.
Baseline, 3 minutes after sternotomy, and postoperative 6 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Intensity Assessed by the Visual Analogue Scale
Tidsramme: At 1, 2, 4, 8, 12, and 24 hours after extubation
Postoperative pain intensity was assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain.
At 1, 2, 4, 8, 12, and 24 hours after extubation
Additional Analgesic Requirement
Tidsramme: Within the first 24 hours after extubation
The need for rescue analgesia was recorded during the postoperative follow-up period.
Within the first 24 hours after extubation
Total Opioid Consumption
Tidsramme: Within the first 24 postoperative hours
Total opioid consumption delivered by patient-controlled analgesia was recorded.
Within the first 24 postoperative hours
Extubation Time
Tidsramme: Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively
Time to extubation was defined as the duration from the end of surgery to tracheal extubation and was recorded in minutes.
Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively
Intensive Care Unit Length of Stay
Tidsramme: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively
Intensive care unit length of stay was defined as the duration from admission to the intensive care unit after surgery until discharge from the intensive care unit and was recorded in hours.
From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively
Postoperative Nausea and Vomiting
Tidsramme: Within the first 24 postoperative hours
Postoperative nausea and vomiting were recorded as adverse effects.
Within the first 24 postoperative hours

Samarbejdspartnere og efterforskere

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Sponsor

Ataturk University

Efterforskere

  • Studieleder: Muhammed Enes Aydin, professor, Ataturk University Department of Anesthesiology and Reanimation

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

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. januar 2024

Primær færdiggørelse (Faktiske)

1. januar 2026

Studieafslutning (Faktiske)

12. januar 2026

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B.30.2.ATA.0.01.00/353
  • 2023/2 (Anden identifikator: Atatürk University Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared due to participant privacy and confidentiality considerations.

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