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Completed

NCT Number: NCT06826833

ESP Block for Postoperative Analgesia in URS Surgery

The goal of this clinical trial is to determine whether the erector spinae plane (ESP) block provides better pain relief after flexible ureterorenoscopy (URS) surgery compared to standard analgesia alone. Researchers want to know:

Does the ESP block reduce pain levels in the first 24 hours after surgery?

Does it lower the need for opioid pain medication?

Does it reduce the need for additional (rescue) pain treatment?

Does it decrease the likelihood of postoperative nausea and vomiting (PONV)?

Participants will be randomly placed into one of two groups:

ESP Block Group: Participants will receive an ESP block using 20 mL of 0.25% bupivacaine under ultrasound guidance before surgery.

Control Group: Participants will receive standard pain management without a nerve block.

All participants will receive general anesthesia during surgery and multimodal pain management after surgery. Researchers will compare pain scores, opioid use, rescue analgesic needs, and the occurrence of nausea and vomiting between the two groups.

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Key information

Conditions

Analgesia Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Pain Management Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tekirdağ Namık Kemal University Research Hospital

Tekirdağ, 59000, Turkey (Türkiye)

About this study

Intervention Group (ESP Block): Patients will receive 20 mL of 0.25% bupivacaine (1:1 diluted with 0.5% bupivacaine) under ultrasound guidance at the T8-T10 level.

Control Group: No block will be performed, and patients will receive standard postoperative multimodal analgesia.

Procedure Description: The ESP block will be performed under sterile conditions with a high-frequency linear ultrasound probe. A 100-mm echogenic needle will be inserted in a cephalocaudal direction to deposit the local anesthetic deep to the erector spinae muscle at the transverse process level. The correct spread of the anesthetic will be confirmed via real-time ultrasound imaging.

All patients will receive standardized general anesthesia and multimodal analgesia.

Outcome measures include postoperative pain (NRS), opioid consumption, rescue analgesia requirement, and postoperative nausea and vomiting (PONV).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing elective flexible ureterorenoscopy (URS).

Age: 18-65 years.

ASA I-II.

Willing to participate and provide written informed consent.

Exclusion criteria

BMI >35 kg/m².

Allergy to local anesthetics.

Coagulation disorders or use of anticoagulants.

Patients requiring emergency surgery.

Patients with infection at the ESP block site.

Treatment and study plan

Erector Spinae Plane (ESP) Block

Procedure

A regional anesthesia technique in which 20 mL of 0.25% bupivacaine is injected under ultrasound guidance at the T8-T10 level to provide postoperative pain relief.

Primary outcomes

  1. Pain Intensity (Numeric Rating Scale - NRS)

    Time frame: 0, 2, 6, 12, 24 hours postoperatively.

    The Numeric Rating Scale (NRS, 0-10) will be used to assess postoperative pain intensity. Participants will be asked to rate their pain on a scale from 0 to 10, where:

    • 0 = No pain
    • 10 = Worst possible pain

Secondary outcomes

  1. Total Opioid Consumption (IV PCA Morphine Equivalent)

    Time frame: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.

    Description: Total opioid consumption will be recorded in morphine milligram equivalents (MME) administered via IV patient-controlled analgesia (PCA).

  2. Postoperative Nausea and Vomiting (PONV)

    Time frame: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.

    The incidence of postoperative nausea and vomiting (PONV) will be recorded, defined as nausea and/or vomiting requiring treatment with ondansetron IV.

  3. Pain-Free Duration

    Time frame: From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.

    Pain-free duration is defined as the time from the end of surgery to the first request for analgesia (when the patient reports pain requiring medication).

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial

Acronym: ESPURS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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