Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation
4. juni 2026 opdateret af: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study
This randomized prospective study aims to compare the analgesic efficacy of serratus posterior superior intercostal plane (SPSIP) block and standard local anesthetic infiltration in patients undergoing port catheter implantation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This prospective, randomized controlled study evaluates the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block compared with standard local anesthetic infiltration in patients undergoing port catheter implantation. Although the procedure is usually performed under local anesthesia, patients may experience significant pain during port pocket creation.
Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided SPSIP block or local anesthetic infiltration. All patients will receive standardized monitoring and premedication. Pain intensity during different procedural stages, postoperative pain scores, analgesic consumption, and satisfaction levels will be assessed.
The study aims to determine whether SPSIP block improves intraoperative analgesia and reduces analgesic requirements compared to local infiltration.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Outside of the US
-
Diyarbakır, Outside of the US, Tyrkiet (Türkiye), 21070
- Fatma Acil
-
-
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:
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective port catheter implantation
- Ability to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Severe pulmonary disease
- G6PD deficiency
- Pregnancy or breastfeeding
- Inability to assess pain or communicate effectively
- Refusal to participate
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 |
|---|---|
|
Aktiv komparator: Local Infiltration
Participants will receive standard local anesthetic infiltration during port catheter implantation.
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Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
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Eksperimentel: Serratus Posterior Superior Intercostal Plane Block
Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.
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Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity during port pocket creation
Tidsramme: During procedure
|
Pain intensity during port pocket creation measured using the Numeric Rating Scale (0-10), where higher scores indicate greater pain. Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. |
During procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum intraoperative pain score
Tidsramme: During the procedure
|
The highest pain intensity recorded during any procedural stage will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
During the procedure
|
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Pain intensity during procedural stages
Tidsramme: During the procedure
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Pain intensity will be assessed during skin puncture, catheter tunneling, and skin closure using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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During the procedure
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Total supplemental local anesthetic amount
Tidsramme: During the procedure
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Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.
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During the procedure
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Postoperative pain scores
Tidsramme: 0, 2, 6, 12, and 24 hours after the procedure
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Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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0, 2, 6, 12, and 24 hours after the procedure
|
|
Total tramadol consumption
Tidsramme: Within 24 hours after the procedure
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Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams.
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Within 24 hours after the procedure
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Duration of effective analgesia
Tidsramme: Within 24 hours after the procedure
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Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia.
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Within 24 hours after the procedure
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Patient satisfaction score
Tidsramme: After the procedure
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Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
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Surgeon satisfaction score
Tidsramme: After the procedure
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Surgeon satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
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Procedure-related complications
Tidsramme: During and within 24 hours after the procedure
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Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.
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During and within 24 hours after the procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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)
16. maj 2026
Primær færdiggørelse (Faktiske)
4. juni 2026
Studieafslutning (Faktiske)
4. juni 2026
Datoer for studieregistrering
Først indsendt
5. maj 2026
Først indsendt, der opfyldte QC-kriterier
5. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07/04/2026-123
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