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Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy

7. juni 2026 opdateret af: Amr Raafat Mahmoud Seif, Cairo University

Ultrasound Guided Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy: Randomized Controlled Study

This study aims to compare time of first request of analgesia among patients undergoing rhomboid intercostal sub-serratus plane block versus external oblique intercostal block for perioperative pain management in open nephrectomy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Open nephrectomy is a common surgery usually performed for malignant and non-malignant renal pathologies. Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery.

The rhomboid intercostal block has previously been used for pain management in thoracic wall surgery.

Subserratus plane block in the treatment of post-abdominal surgical pain and the combination of the two blocks was subsequently renamed the "RISS block". The nerves targeted by the RISS block include the lateral cutaneous branches of the ventral branches of the thoracic intercostal nerves, located between the rhomboid muscle and the intercostal muscles, and deep into the scapula serratus anterior muscle. RISS block provides analgesia from T4 to T9 thoracic dermatomes and has been used in postoperative pain management for thoracic surgeries and upper abdominal surgeries.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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:

  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status II, III.
  • Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2.
  • Patients undergoing open nephrectomy.

Exclusion Criteria:

  • Patient refusal.
  • BMI <20 kg/m2 and >35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • History of psychiatric and cognitive disorders or chronic pain.
  • Contraindication to regional anesthesia e.g pre- existing peripheral neuropathies.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Physical status ASA IV.
  • Coagulopathy with INR ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group (A)
Patients will receive the rhomboid intercostal subserratus plane block.
Andet: Rhomboid intercostal subserratus plane block
Patients will receive the rhomboid intercostal subserratus plane block.
Eksperimentel: Group (B)
Patients will receive the external oblique intercostal block.
Andet: External oblique intercostal block
Patients will receive the external oblique intercostal block.
Aktiv komparator: Control group
Patients will not receive any interventions (IV morphine 0.1mg/kg after induction of general anesthesia).
Medicin: Intravenous morphine
Patients will not receive any interventions (Intravenous morphine 0.1mg/kg after induction of general anesthesia).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of first request of analgesia
Tidsramme: 24 hours postoperatively
Time of first request of analgesia will be recorded from the end of surgery till first dose of morphine administrated.
24 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate
Tidsramme: 24 hours postoperatively
Heart rate will be noted immediately on arrival and at 0, 4, 8, 12, 18 and 24 h postoperatively.
24 hours postoperatively
Mean arterial blood pressure
Tidsramme: 24 hours postoperatively
Mean arterial blood pressure will be noted immediately on arrival and at 0, 4, 8, 12, 18 and 24 h postoperatively.
24 hours postoperatively
Total amount of fentanyl
Tidsramme: 24 hours postoperatively
Fentanyl 0.5 μg / kg will be given in case of heart rate or mean arterial blood pressure ≥ 20% of the baseline
24 hours postoperatively
Total morphine consumption
Tidsramme: 24 hours postoperatively
Intravenous morphine (3 mg) will be provided as rescue of analgesia. The total amount of morphine given in 24 h will be recorded.
24 hours postoperatively
Degree of pain
Tidsramme: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be recorded at 30 minutes, 2,4, 8, 12, 16, 24 hours postoperatively.
24 hours postoperatively
Incidence of block related complications
Tidsramme: 24 hours postoperatively
Incidence of block related complications such as local anesthetic toxicity, hematoma formation, and pneumothorax will be recorded.
24 hours postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

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)

2. maj 2026

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AP2604-501-160-209

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner