Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study
30 maj 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Erzurum, Turkiet (Türkiye), 25240
- Ataturk University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: Standard Analgesia Group
Participants in this group received standard perioperative systemic analgesia without local anesthetic intervention at the surgical site.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Salivary Opiorphin Level
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Pain Intensity Assessed by the Visual Analogue Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Muhammed Enes Aydin, professor, Ataturk University Department of Anesthesiology and Reanimation
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2024
Primärt slutförande (Faktisk)
1 januari 2026
Avslutad studie (Faktisk)
12 januari 2026
Studieregistreringsdatum
Först inskickad
21 maj 2026
Först inskickad som uppfyllde QC-kriterierna
30 maj 2026
Första postat (Faktisk)
2 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B.30.2.ATA.0.01.00/353
- 2023/2 (Annan identifierare: Atatürk University Clinical Research Ethics Committee)
Plan för individuella deltagardata (IPD)
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NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
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