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ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy

8. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

84

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Şeyma Nur Güner Zengin, MD
  • Telefonnummer: +90 212 414 71 71
  • E-post: snurguner@gmail.com

Studer Kontakt Backup

  • Navn: Nalan Saygı Emir, MD, Associate Professor
  • Telefonnummer: +90 212 414 71 71
  • E-post: nasaemir@hotmail.com

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group E
Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.
Fremgangsmåte: 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.
Andre navn:
  • ESP BLock
Group X
Participants undergoing laparoscopic nephrectomy who receive External Oblique Rectus Abdominis (EXORA) block as part of routine clinical care.
Fremgangsmåte: 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.
Andre navn:
  • EXORA Block

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Pain Score (NRS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rescue Analgesic Requirement
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Nausea and Vomiting (PONV) Score
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. august 2029

Studiet fullført (Antatt)

1. august 2029

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BEAH 2026/191

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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