- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Giza Governorate
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Giza, Giza Governorate, Egypt, 3030
- Helwan University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: external oblique intercostal fascial plane block
|
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).
|
|
Aktiv komparator: rectus sheath block
|
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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total postoperative morphine consumption in milligrams during the first 24 hours after surgery
Tidsramme: First 24 hours postoperatively
|
Total cumulative morphine requirement administered for postoperative analgesia during the first 24 hours following paraumbilical hernia repair surgery, measured in milligrams (mg).
|
First 24 hours postoperatively
|
|
Number of participants experiencing block-related or postoperative complications within 3 months after surgery
Tidsramme: 3 months after surgery
|
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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EOIPB
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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