Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study
30. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Erzurum, Tyrkia (Türkiye), 25240
- Ataturk University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Ultrasound-guided parasternal block was performed with local anesthetic before surgical incision.
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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.
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Local anesthetic infiltration was performed at the surgical wound site before surgical incision.
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Ingen inngripen: Standard Analgesia Group
Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Salivary Opiorphin Level
Tidsramme: Baseline, 3 minutes after sternotomy, and postoperative 6 hours
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Salivary opiorphin levels were measured using ELISA to evaluate the analgesic effect of the study interventions.
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Baseline, 3 minutes after sternotomy, and postoperative 6 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity Assessed by the Visual Analogue Scale
Tidsramme: At 1, 2, 4, 8, 12, and 24 hours after extubation
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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.
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At 1, 2, 4, 8, 12, and 24 hours after extubation
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Additional Analgesic Requirement
Tidsramme: Within the first 24 hours after extubation
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The need for rescue analgesia was recorded during the postoperative follow-up period.
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Within the first 24 hours after extubation
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Total Opioid Consumption
Tidsramme: Within the first 24 postoperative hours
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Total opioid consumption delivered by patient-controlled analgesia was recorded.
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Within the first 24 postoperative hours
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Extubation Time
Tidsramme: Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively
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Time to extubation was defined as the duration from the end of surgery to tracheal extubation and was recorded in minutes.
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Immediately after surgery until tracheal extubation, assessed up to 24 hours postoperatively
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Intensive Care Unit Length of Stay
Tidsramme: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively
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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.
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From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 7 days postoperatively
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Postoperative Nausea and Vomiting
Tidsramme: Within the first 24 postoperative hours
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Postoperative nausea and vomiting were recorded as adverse effects.
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Within the first 24 postoperative hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Muhammed Enes Aydin, professor, Ataturk University Department of Anesthesiology and Reanimation
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Parida SK, Guruprasad T, Krishnakumar VB, Ravi RP. A study of salivary opiorphin levels using different anesthetic drugs and techniques - A randomized controlled clinical study. J Stomatol Oral Maxillofac Surg. 2018 Jun;119(3):169-171. doi: 10.1016/j.jormas.2017.11.017. Epub 2017 Dec 13.
- Ozdogan MS, Gungormus M, Ince Yusufoglu S, Ertem SY, Sonmez C, Orhan M. Salivary opiorphin in dental pain: A potential biomarker for dental disease. Arch Oral Biol. 2019 Mar;99:15-21. doi: 10.1016/j.archoralbio.2018.12.006. Epub 2018 Dec 15.
- Gavcar EG, Kabukcu Basay B, Avci E, Basay O. Relationship between saliva opiorphin levels, pain threshold, and cutting number in adolescents with non suicidal self injury. J Psychiatr Res. 2022 Jul;151:611-618. doi: 10.1016/j.jpsychires.2022.05.030. Epub 2022 May 24.
- Yilmaz N, Baygin O, Tuzuner T, Mentese A, Demir S. Determination of the effect of two different methods of dental anesthesia on pain level in pediatric patients: A cross-over, randomized trial. Niger J Clin Pract. 2022 Nov;25(11):1853-1863. doi: 10.4103/njcp.njcp_289_22.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2024
Primær fullføring (Faktiske)
1. januar 2026
Studiet fullført (Faktiske)
12. januar 2026
Datoer for studieregistrering
Først innsendt
21. mai 2026
Først innsendt som oppfylte QC-kriteriene
30. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B.30.2.ATA.0.01.00/353
- 2023/2 (Annen identifikator: Atatürk University Clinical Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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