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ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy

8 juni 2026 bijgewerkt door: Beyhan Guner, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Prospective Comparison of Postoperative Analgesic Effects of ESP Block and EXORA Block in Nephrectomy Cases

The goal of this observational study is to learn about the effects of two pain control techniques used after laparoscopic nephrectomy (kidney removal surgery) in adults. The study will compare Erector Spinae Plane (ESP) block and External Oblique Rectus Abdominis (EXORA) block, which are both used as part of routine medical care to help control pain after surgery.

The main questions it aims to answer are:

Do ESP block and EXORA block differ in how well they control pain after surgery? Do ESP block and EXORA block differ in their effects on recovery quality and the need for additional pain medication?

Researchers will compare participants who receive ESP block with participants who receive EXORA block as part of routine clinical care.

Participants will:

Undergo laparoscopic nephrectomy according to routine clinical practice. Receive either ESP block or EXORA block based on the treating anesthesiologist's usual clinical preference.

Complete a recovery questionnaire before surgery and 24 hours after surgery. Have pain scores, use of additional pain medication, nausea and vomiting, and other routine postoperative measurements recorded during the first 24 hours after surgery.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In routine practice at our institution, anesthesia clinicians performing laparoscopic nephrectomy administer either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either ESP or EXORA block will be included and evaluated observationally. Block types other than these two will not be included.

All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, and administering the QoR-15 questionnaire preoperatively and at postoperative 24 hours.

Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied. Anesthesia induction is performed using standard agents and general anesthesia is maintained according to the clinician's routine practice.

For postoperative analgesia, all patients routinely receive intravenous paracetamol 1 g every 8 hours. Rescue analgesia consists of intravenous tramadol 1 mg/kg when NRS ≥4. After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9.

Postoperative nausea and vomiting (PONV) are assessed using a verbal descriptive scale (0-4) and intravenous ondansetron 4 mg is administered for PONV ≥2.

Studietype

Observationeel

Inschrijving (Geschat)

84

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Şeyma Nur Güner Zengin, MD
  • Telefoonnummer: +90 212 414 71 71
  • E-mail: snurguner@gmail.com

Studie Contact Back-up

  • Naam: Nalan Saygı Emir, MD, Associate Professor
  • Telefoonnummer: +90 212 414 71 71
  • E-mail: nasaemir@hotmail.com

Studie Locaties

  • Turkije (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkije (Türkiye), 34147
        • Werving
        • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients aged 18-80 years undergoing laparoscopic nephrectomy and receiving either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block according to routine clinical practice.

Beschrijving

Inclusion Criteria:

  • Age between 18 and 80 years
  • Patients scheduled for laparoscopic nephrectomy
  • Patients for whom Erector Spinae Plane (ESP) block or External Oblique Rectus Abdominis (EXORA) block has been selected by the treating clinician
  • ASA physical status I-III

Exclusion Criteria:

  • No regional block performed in routine clinical practice
  • Body mass index (BMI) greater than 35 kg/m²
  • History of opioid dependence
  • Alcohol or other substance dependence
  • Psychiatric disease, mental retardation, dementia, or any condition impairing pain perception or pain assessment

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Group E
Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.
Procedure: Erector Spinae Plane Block
An ultrasound-guided Erector Spinae Plane (ESP) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is placed over the T10 transverse process on the surgical side. The needle is advanced into the fascial plane between the erector spinae muscle and the transverse process. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
Andere namen:
  • ESP BLock
Group X
Participants undergoing laparoscopic nephrectomy who receive External Oblique Rectus Abdominis (EXORA) block as part of routine clinical care.
Procedure: External Oblique Rectus Abdominis Block
An ultrasound-guided External Oblique Rectus Abdominis (EXORA) block is performed under general anesthesia prior to extubation as part of routine clinical practice. After aseptic preparation, a linear ultrasound probe is positioned in the parasternal sagittal plane lateral to the xiphoid process at the level of the 8th costal cartilage on the surgical side. The needle is advanced into the fascial plane between the rectus abdominis and external oblique muscles. Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected. The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
Andere namen:
  • EXORA Block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Pain Score (NRS)
Tijdsspanne: Postoperative 1, 6, 12, and 24 hours
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 6, 12, and 24 hours after surgery and will be compared between Group E and Group X. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Postoperative 1, 6, 12, and 24 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rescue Analgesic Requirement
Tijdsspanne: First 24 hours after surgery
The requirement for rescue analgesia and the total amount of postoperative tramadol consumption during the first 24 hours will be recorded and compared between Group E and Group X.
First 24 hours after surgery
Quality of Recovery (QoR-15 Score)
Tijdsspanne: Preoperative baseline and postoperative 24th hour
Quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. Scores will be compared between Group E and Group X. The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Preoperative baseline and postoperative 24th hour

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Nausea and Vomiting (PONV) Score
Tijdsspanne: Postoperative 1, 6, 12, and 24 hours
Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes). Scores will be compared between Group E and Group X.
Postoperative 1, 6, 12, and 24 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 augustus 2029

Studie voltooiing (Geschat)

1 augustus 2029

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BEAH 2026/191

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the study protocol does not include a data-sharing plan and the collected data will be used only for the purposes of the current study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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