Erector Spinae Plane Block for Percutaneous Nephrolithotomy

NCT07457983 | Not Yet Recruiting

• 1 other identifier: ADYU-AR-FT-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Percutaneous Nephrolithotomy (PCNL); Nephrolithiasis; Renal Calculi

Keywords

Percutaneous Nephrolithotomy; Erector spinae plane block; Opioid consumption; Numerical pain scores (NRS); Recovery quality (QoR-15T)

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Tramadol Consumption within 24 Hours

  Total dose of intravenous tramadol (mg) administered as rescue analgesia during the first 24 hours after surgery.

  0-24 hours postoperatively

Secondary Outcomes (3)

• Intraoperative Remifentanil Consumption

  İntraoperative period

• Postoperative Pain Scores (NRS)

  Postoperative 0th, 2nd, 4th, 6th, 12th and 24th hours

• QoR-15T (Turkish) quality of recovery scale

  Postoperative 24th hours, based on a single assessment

Study Arms (2)

Block group

EXPERIMENTAL

Standard pain management + Erector spinae plane block

Procedure: Erector Spinae Plane Block

Control group

NO INTERVENTION

Patients will receive standard general anesthesia and perioperative systemic analgesia, but erector spinae plane block will not be performed.

Interventions

Erector Spinae Plane Block PROCEDURE

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

Block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fadime Tosun: lead

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fadime Tosun, Asst. Prof.

  Adiyaman University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadime Tosun, Asst. Prof.

CONTACT

+905322375284; fadimetosun@gmail.com

Nezir Yılmaz, Assoc. Prof.

CONTACT

+905068939496; yilmaznezir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers performing the block procedures were not involved in the postoperative assessment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to two groups using the sealed-envelope Arm 1:Patients will receive erector spinae plane block (ESPB) in addition to standard care. Arm 2: Patients will receive only standard pain management.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share