- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07577908
Analgesic Efficiency of SIPSPB vs ICNB in VATS Surgery
Comparison Of The Analgesic Effectiveness Of Ultrasonography-Guided Serratus Posterıor Superior Intercostal Plane (SPSIP) Block And Intercostal Nerve (ICN) Block In Video-Assisted Thoracoscopic Surgery Patients
Studieoversigt
Status
Detaljeret beskrivelse
In this prospective observational study, patients included in the study will receive Serratus Posterior Superior Intercostal Plane (SPSIP) block and Intercostal Nerve (ICN) block for postoperative analgesia at the end of surgery. The SPSIP block will be performed by the anesthesiologist under ultrasound guidance immediately after skin closure and before extubation, while the ICN block will be performed by the surgeon under direct vision immediately before skin closure.
At the end of surgery, patients will receive 1000 mg paracetamol and 50 mg dexketoprofen during skin closure. Upon arrival at the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing tramadol. At postoperative reassessment, patients with a Numerical Pain Rating Scale (NPRS) score greater than 4 despite PCA use will receive a rescue analgesic dose of 50 mg dexketoprofen.
Postoperative pain intensity will be assessed using the NPRS (Numerical Pain Rating Scale) at 1, 4, 6, 12, 18, and 24 hours postoperatively, both at rest and during coughing. Total opioid consumption, rescue analgesic use, and postoperative complications will be recorded.
Patients will be informed about their level of surgical satisfaction 24 hours after surgery, and this information will be recorded.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Abdullah Bozkurt
- Telefonnummer: +905369985015
- E-mail: abdullahbozkurtdr@gmail.com
Studiesteder
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İzmit, Tyrkiet (Türkiye)
- Rekruttering
- Kocaeli City Hospital
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Kontakt:
- Ayşe Z Turan Cıvraz, Assoc. Prof.
- Telefonnummer: +905054695850
- E-mail: ayse.zeynep@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Aged 18-80 years,
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients who have provided informed consent to participate in the study
Exclusion Criteria:
- Patients who refuse to participate in the study by not signing the informed consent
- Patients classified as ASA > 3, according to the system established by the American Society of Anesthesiologists
- Patients unable to understand the use of the NPR Scale or the PCA device that will be used for postoperative analgesia
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Patients with allergies to analgesic and/or anesthetic drugs
- Infection at the block injection site
- Patients whose surgical procedure is intraoperatively converted to an open pulmonary resection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Group SPSIP Block
In patients meeting the inclusion criteria for the study, an ultrasound-guided interfacial plane block is applied between the posterior superior serratus muscle and the underlying ribs in patients undergoing SPSIP block after VATS.
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Group ICN Block
Patients meeting the inclusion criteria for the study who will undergo intercostal nerve block after VATS will have a total of 10 ml of 0.5% bupivacaine applied to two segments (upper and lower segments of the incision line) under direct vision by the surgeon while the patient is in the lateral decubitus position at the end of the operation and immediately before skin closure.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Postoperative pain intensity
Tidsramme: 24 hours after the end of surgery
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In both study groups, postoperative pain intensity at rest and with coughing was measured using the Numerical Pain Rating Scale (NPRS), a numerical scale ranging from 0 to 10 (0 meaning no pain, 10 meaning the most severe pain imaginable).
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24 hours after the end of surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patienttilfredshedsscore
Tidsramme: 24 timer efter operationen
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evalueret ved hjælp af en 5-punkts Likert-skala (1=meget utilfreds, 5=meget tilfreds)
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24 timer efter operationen
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Total opioid drug consumption
Tidsramme: 24 hours after the end of surgery
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The total amount of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery
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24 hours after the end of surgery
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Consumption of rescue analgesics
Tidsramme: 24 hours after the end of surgery
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The total dose of dexketoprofen required by the patient during each specified time interval in the first 24 hours after surgery.
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24 hours after the end of surgery
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Postoperative Complications
Tidsramme: 24 hours after the end of surgery
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Postoperative complications such as nausea, vomiting or other adverse events will be recorded
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24 hours after the end of surgery
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Ayşe Z Turan Cıvraz, Assoc. Prof., Kocaeli City Hospital
Publikationer og nyttige links
Generelle publikationer
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 250125
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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