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Modified External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block for Open Nephrectomy (EOIPB-ON)

21. juli 2026 opdateret af: Onur Baran, Namik Kemal University

Comparison of Modified External Oblique Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Prospective Randomized Controlled Trial

This prospective, randomized, assessor-blinded clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified External Oblique Intercostal Plane Block (EOIPB) in patients undergoing elective open nephrectomy under general anesthesia. Sixty adult patients will be randomized to receive either ESPB or EOIPB before surgical incision. All participants will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The study aims to determine whether one fascial plane block technique provides superior postoperative pain control and recovery following open nephrectomy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Open nephrectomy is associated with substantial postoperative pain that may impair recovery, delay mobilization, and increase opioid consumption. Regional anesthesia techniques have become important components of multimodal analgesia strategies aimed at improving postoperative outcomes while minimizing opioid-related adverse effects.

The erector spinae plane block (ESPB) and modified external oblique intercostal plane block (EOIPB) are ultrasound-guided fascial plane blocks that have demonstrated effectiveness in providing thoracoabdominal analgesia. However, evidence directly comparing these techniques in patients undergoing open nephrectomy remains limited.

This study is a prospective, randomized, controlled, assessor-blinded clinical trial conducted at a single tertiary academic center. Sixty patients aged 18 to 65 years with ASA physical status I-II who are scheduled for elective open nephrectomy will be enrolled and randomized in a 1:1 ratio to one of two study groups.

Participants assigned to the ESPB group will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Participants assigned to the EOIPB group will receive an ultrasound-guided modified external oblique intercostal plane block using the same volume and concentration of local anesthetic.

All patients will receive standardized general anesthesia, postoperative intravenous patient-controlled analgesia with tramadol, scheduled paracetamol, and rescue analgesics according to institutional protocols. Patients will be followed in the post-anesthesia care unit and at postoperative 2, 6, 12, and 24 hours.

The primary objective is to compare postoperative pain intensity between the two groups during the first 24 postoperative hours. Secondary objectives include comparison of opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, and perioperative hemodynamic parameters.

The results of this study may help identify the optimal regional analgesia technique for patients undergoing open nephrectomy and contribute to enhanced postoperative recovery.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Tekirdağ
      • Tekirdağ, Tekirdağ, Tyrkiet (Türkiye), 59000
        • Tekirdağ Namık Kemal University
        • Kontakt:

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 between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for elective open nephrectomy.
  • Able and willing to provide written informed consent.
  • Willing to comply with study procedures.

Exclusion Criteria:

  • Refusal to participate or inability to provide informed consent.
  • Emergency surgery.
  • Body mass index (BMI) greater than 35 kg/m².
  • Known allergy or hypersensitivity to local anesthetics.
  • Infection at the planned block insertion site.
  • Coagulopathy or ongoing anticoagulant therapy.
  • Pregnancy or breastfeeding.
  • Prisoners or other vulnerable populations unable to provide independent consent.

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
Eksperimentel: ESPB Group
Participants will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.
Procedure: Erector Spinae Plane Block
Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
Eksperimentel: EOIPB Group
Participants will receive an ultrasound-guided modified external oblique intercostal plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.
Procedure: Modified External Oblique Intercostal Plane Block
Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity at rest
Tidsramme: 0, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity will be assessed at rest using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
0, 2, 6, 12, and 24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity during movement
Tidsramme: 0, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity will be assessed during movement using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
0, 2, 6, 12, and 24 hours after surgery
Total Opioid Consumption
Tidsramme: 24 hours after surgery
Total postoperative tramadol consumption recorded from patient-controlled analgesia during the first 24 postoperative hours.
24 hours after surgery
Rescue Analgesic Requirement
Tidsramme: 24 hours after surgery
Number of patients requiring rescue analgesia during the first 24 postoperative hours.
24 hours after surgery
Postoperative Nausea and Vomiting
Tidsramme: 24 hours after surgery
Incidence of postoperative nausea and vomiting during the first 24 postoperative hours.
24 hours after surgery
Heart Rate
Tidsramme: From induction of anesthesia until the end of surgery
Intraoperative heart rate measured in beats per minute at predefined intraoperative time points.
From induction of anesthesia until the end of surgery
Mean Arterial Pressure
Tidsramme: From induction of anesthesia until the end of surgery
Intraoperative mean arterial pressure measured in millimeters of mercury at predefined intraoperative time points.
From induction of anesthesia until the end of surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Namik Kemal 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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TNKU-EOIPB003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

De-identified individual participant data are not planned to be shared because no formal data-sharing infrastructure or approved data-sharing plan has been established for this study.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Erector Spinae Plane Block

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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