NCT07640282

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
39mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Aug 2029

Study Start

First participant enrolled

June 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3.2 years

First QC Date

June 4, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Erector Spinae Plane BlockEXORA BlockLaparoscopic NephrectomyPostoperative AnalgesiaQuality of Recovery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score (NRS)

    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

Secondary Outcomes (2)

  • Rescue Analgesic Requirement

    First 24 hours after surgery

  • Quality of Recovery (QoR-15 Score)

    Preoperative baseline and postoperative 24th hour

Other Outcomes (1)

  • Postoperative Nausea and Vomiting (PONV) Score

    Postoperative 1, 6, 12, and 24 hours

Study Arms (2)

Group E

Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.

Procedure: Erector Spinae Plane 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

Interventions

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.

Also known as: ESP BLock
Group E

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.

Also known as: EXORA Block
Group X

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 40161911BACKGROUND
  • 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.

    PMID: 33403545BACKGROUND
  • 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.

    PMID: 40760576BACKGROUND
  • 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.

    PMID: 38167138BACKGROUND
  • 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.

    PMID: 41479827BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Şeyma Nur Güner Zengin, MD

CONTACT

Nalan Saygı Emir, MD, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 10, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations