Erector Spinae Plane Block for Percutaneous Nephrolithotomy

March 9, 2026 updated by: Fadime Tosun

Perioperative Efficacy of Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy

Percutaneous nephrolithotomy (PCNL) is an effective standard urological procedure for the fragmentation and removal of large renal calculi. Although PCNL is performed as a minimally invasive technique, dilation of the renal capsule and parenchymal tract, as well as peritubular distension caused by the nephrostomy tube, may result in severe postoperative pain. Various analgesic strategies have been described in the literature for postoperative pain management following PCNL. These include systemic opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and several regional analgesia techniques. However, due to their adverse effect profiles, opioids and NSAIDs are not ideal options, particularly in patients with renal dysfunction. Regional techniques that have been utilized include local infiltration, intercostal nerve blocks, paravertebral blocks, and epidural analgesia.

The kidney is primarily innervated between the T10 and L1 segments, whereas the ureter receives innervation from T10 to L2. Based on this anatomical knowledge, unilateral regional blockade between T10 and L2 can provide adequate analgesia for PCNL procedures. Thoracic paravertebral block was previously a commonly preferred technique; however, it may be associated with complications such as intravascular injection, unintended epidural or intrathecal spread, and pneumothorax during its performance. In recent years, the number of reports describing the use of the erector spinae plane block (ESPB) as part of multimodal anesthesia for postoperative analgesia has increased. In ESPB, local anesthetic is injected into the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, and has been reported to spread to multiple paravertebral spaces. ESPB is considered a peri-paravertebral block that can affect both visceral and somatic pain pathways.

The aim of this study is to evaluate the effect of ultrasound-guided erector spinae plane block on intraoperative and postoperative opioid consumption, postoperative pain scores, and quality of recovery in patients undergoing percutaneous nephrolithotomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is designed to evaluate the perioperative efficacy of ultrasound-guided ESPB in adult patients undergoing percutaneous nephrolithotomy under general anesthesia.

After enrollment, patients will be randomly allocated into two groups using a closed-envelope method: an ESPB group and a control group. All patients will receive a standardized general anesthesia protocol. Anesthesia induction will be performed with propofol 2 mg/kg Propofol®, Polifarma İlaç San.ve Tic. A.Ş., Türkiye), rocuronium 0.6 mg/kg (Esmeron®, Merck Sharp Dohme İlaçları LTD Şti, Türkiye)as neuromuscular blocker, and remifentanil 1 µg/kg (ultan, centurion pharma, İstanbul, Türkiye) as opioid. Additional rocuronium 0.1 mg/kg will be administered intraoperatively as needed to maintain muscle relaxation. Anesthesia will be maintained with 2% sevoflurane (Sevorane®, Abbott, Chicago, ABD) in 50% oxygen and a continuous infusion of remifentanil at 0.1-1 µg/kg/min, titrated according to hemodynamic responses. Invasive arterial blood pressure monitoring will be used for close hemodynamic follow-up in all patients.

In the ESPB group, following induction of general anesthesia and prior to surgical incision, an ultrasound-guided ESPB will be performed at the T10 transverse process level on the side of the surgical kidney. Under aseptic conditions, using an in-plane technique, a total of 20 mL of 0.25% bupivacaine (Marcaine® %0,5, AstraZeneca, İstanbul, Türkiye)will be injected between the erector spinae muscle and the transverse process. In the control group, no additional regional block or sham procedure will be performed; patients will undergo surgery under general anesthesia with the same standardized systemic analgesia protocol as the ESPB group.

Intraoperative hemodynamic parameters, including mean arterial pressure and heart rate, will be recorded at predefined time points, and total intraoperative remifentanil consumption will be documented. At the end of surgery, all patients will receive 15 mg/kg paracetamol and 0.5 mg/kg meperidine intravenously as part of the standard postoperative analgesic regimen. During postoperative ward follow-up, all patients will receive 15 mg/kg paracetamol four times daily. Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at 0, 2, 4, 6, 12, and 24 hours after surgery. For patients with NRS ≥ 3, intravenous tramadol 1 mg/kg will be administered as rescue analgesia, and total postoperative tramadol consumption within the first 24 hours will be recorded.

Postoperative nausea and vomiting will be evaluated at 0, 2, 4, 6, 12, and 24 hours postoperatively, and the presence or absence of symptoms will be documented. Quality of recovery will be assessed at 24 hours after surgery using the Turkish validated version of the 15-item Quality of Recovery questionnaire (QoR-15T). The total QoR-15T score ranges from 0 to 150, with higher scores indicating better quality of recovery. Postoperative pain assessments and QoR-15T evaluations will be performed by nurses who are blinded to group allocation, ensuring assessor blinding.

The primary objective of this trial is to determine whether the addition of ESPB to standard general anesthesia reduces postoperative opioid consumption within the first 24 hours after percutaneous nephrolithotomy compared with standard systemic analgesia alone. Secondary objectives include the comparison of postoperative pain scores at predefined time points, intraoperative remifentanil requirements, hemodynamic stability, incidence of postoperative nausea and vomiting, and quality of recovery as measured by the QoR-15T. This study is expected to provide clinically relevant evidence regarding the analgesic efficacy and recovery benefits of ESPB in patients undergoing percutaneous nephrolithotomy.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective percutaneous nephrolithotomy under general anesthesia.
  • Able to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Age < 18 years.
  • ASA physical status III-IV.
  • Refusal to participate in the study.
  • Known allergy or contraindication to local anesthetics (bupivacaine), opioids, or study medications.
  • Coagulopathy or anticoagulant therapy contraindicating regional block.
  • Infection at the injection site.
  • Severe psychiatric or cognitive disorder precluding reliable pain assessment or questionnaire completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients will receive standard general anesthesia and perioperative systemic analgesia, but erector spinae plane block will not be performed.
Experimental: Block group
Standard pain management + Erector spinae plane block
Procedure: Erector Spinae Plane Block
In addition to standard general anesthesia, patients are scheduled to undergo an ultrasound-guided erector spinae plane block at the T10 transverse process level using 20 ml of 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Postoperative Tramadol Consumption within 24 Hours
Time Frame: 0-24 hours postoperatively
Total dose of intravenous tramadol (mg) administered as rescue analgesia during the first 24 hours after surgery.
0-24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoR-15T (Turkish) quality of recovery scale
Time Frame: Postoperative 24th hours, based on a single assessment
The Quality of Recovery-15 (QoR-15) at 24 hours scale is a patient-reported outcome questionnaire that measures the quality of postoperative recovery. The validity of Quality of Recovery-15 (QoR-15) has been proven in many languages. In our study, the Turkish Quality of Recovery-15 (QoR-15T) will be used to measure postoperative recovery in the Turkish population. The Turkish Quality of Recovery-15 (QoR-15T) scale consists of 2 parts and a total of 15 questions are asked to patients. Patients can score each question between 0 and 10, so the total Turkish Quality of Recovery-15 (QoR-15T) score can range from 0 to 150. A higher score indicates a better recovery quality.
Postoperative 24th hours, based on a single assessment
Intraoperative Remifentanil Consumption
Time Frame: İntraoperative period
Total dose of remifentanil (µg) used intraoperatively
İntraoperative period
Postoperative Pain Scores (NRS)
Time Frame: Postoperative 0th, 2nd, 4th, 6th, 12th and 24th hours
Postoperative pain scores will be assesed with numerical pain scores at postoperative period. NRS score will range to 0-10. O refers to no pain and 10 refers to the worst pain ever had.
Postoperative 0th, 2nd, 4th, 6th, 12th and 24th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fadime Tosun

Investigators

  • Principal Investigator: Fadime Tosun, Asst. Prof., Adiyaman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADYU-AR-FT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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