- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07640282
ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Şeyma Nur Güner Zengin, MD
- Telefonnummer: +90 212 414 71 71
- E-mail: snurguner@gmail.com
Undersøgelse Kontakt Backup
- Navn: Nalan Saygı Emir, MD, Associate Professor
- Telefonnummer: +90 212 414 71 71
- E-mail: nasaemir@hotmail.com
Studiesteder
-
-
Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye), 34147
- Rekruttering
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Group E
Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.
|
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 navne:
|
|
Group X
Participants undergoing laparoscopic nephrectomy who receive External Oblique Rectus Abdominis (EXORA) block as part of routine clinical care.
|
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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Okmen K, Demirel A, Dogan AK, Ertus CY. Application of EXORA block for analgesia following hand-assisted laparoscopic donor nephrectomy (HALDN). Indian J Anaesth. 2025 Mar;69(3):324-326. doi: 10.4103/ija.ija_1263_24. Epub 2025 Feb 17. No abstract available.
- Nalbant B, Donmez A, Altinsoy S, Kavak Akelma F. Efficacy of OSTAP, ESP block, trocar site local anesthetic injection in elective laparoscopic cholecystectomy: A randomized controlled trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43607. doi: 10.1097/MD.0000000000043607.
- Yang M, Cao L, Lu T, Xiao C, Wu Z, Jiang X, Wang W, Li H. Ultrasound-guided erector spinae plane block for perioperative analgesia in patients undergoing laparoscopic nephrectomies surgery: a randomized controlled trial. Trials. 2024 Jan 2;25(1):10. doi: 10.1186/s13063-023-07866-0.
- Amir S, Siddiqui AH, Haris M, Laique F, Amini B, Mehboob M, Mohiuddin M, Azam MM, Mukhtar S, Akram Z, Zainab B, Rizwan S, Moeed A, Surani S. Ultrasound-guided erector spinae plane block for perioperative analgesia in laparoscopic nephrectomy: A systematic review and meta-analysis. World J Nephrol. 2025 Dec 25;14(4):110268. doi: 10.5527/wjn.v14.i4.110268.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BEAH 2026/191
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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