- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07601945
External Oblique Intercostal Fascial Plane Block Versus Rectus Sheath Block for Postoperative Analgesia
External Oblique Intercostal Fascial Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Paraumbilical Hernia Repair Surgery
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Background: Paraumbilical hernia repair is a frequently performed surgical procedure, often associated with significant postoperative pain and delayed recovery, which are major concerns for patients.
Objectives: This study aimed to compare the analgesic efficacy of the external oblique intercostal fascial plane block (EOIPB) versus the rectus sheath block (RSB) for managing postoperative pain following paraumbilical hernioplasty.
Methods: This prospective, randomized, single-blinded study enrolled 60 patients, divided into two groups (EOIPB and RSB), each comprising 30 participants. Blocks were administered after general anesthesia and prior to surgery. Patient demographics (age, weight), surgical duration, pain scores (measured by Numeric Rating Scale - NRS), total postoperative morphine consumption, intraoperative fentanyl consumption, and hemodynamic parameters (mean arterial pressure - MAP and heart rate - HR) were assessed.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Giza Governorate
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Giza, Giza Governorate, Egypten, 3030
- Helwan university
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I or II [16], and scheduled for elective paraumbilical hernioplasty.
Exclusion Criteria:
- Patients with a history of prolonged opioid medication, allergy to local anesthetics, pregnancy, infection at the injection site, and/or coagulopathy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: external oblique intercostal fascial plane block
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After the induction of general anesthesia and approximately 15 minutes before the surgical incision, patients were randomly assigned to receive either the EOIPB (Group A) or the RSB (Group B).
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Aktiv komparator: rectus sheath block
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After the induction of general anesthesia and approximately 15 minutes before the surgical incision, patients were randomly assigned to receive either the EOIPB (Group A) or the RSB (Group B).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total postoperative morphine consumption in milligrams during the first 24 hours after surgery
Tidsramme: First 24 hours postoperatively
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Total cumulative morphine requirement administered for postoperative analgesia during the first 24 hours following paraumbilical hernia repair surgery, measured in milligrams (mg).
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First 24 hours postoperatively
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Number of participants experiencing block-related or postoperative complications within 3 months after surgery
Tidsramme: 3 months after surgery
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Assessment of postoperative and block-related complications including local anesthetic toxicity, hematoma, infection, nausea/vomiting, respiratory depression, and other adverse events recorded during the follow-up period.
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3 months after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EOIPB
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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