ESP Block for Postoperative Analgesia in URS Surgery

NCT06826833 | Completed

• 1 other identifier: TNKU-URS001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Postoperative Pain Management; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (Numeric Rating Scale - NRS)

  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

  0, 2, 6, 12, 24 hours postoperatively.

Secondary Outcomes (3)

• Total Opioid Consumption (IV PCA Morphine Equivalent)

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

• Postoperative Nausea and Vomiting (PONV)

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

• Pain-Free Duration

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

Study Arms (2)

ESP Block Group

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane (ESP) Block

Control Group

NO INTERVENTION

Patients will receive routine multimodal analgesia without an ESP block.

Interventions

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.

ESP Block Group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective flexible ureterorenoscopy (URS).
• Age: 18-65 years.
• ASA I-II.
• Willing to participate and provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdağ Namık Kemal University Research Hospital

Tekirdağ, 59000, Turkey (Türkiye)

Location

Related Publications (2)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Bryniarski P, Bialka S, Kepinski M, Szelka-Urbanczyk A, Paradysz A, Misiolek H. Erector Spinae Plane Block for Perioperative Analgesia after Percutaneous Nephrolithotomy. Int J Environ Res Public Health. 2021 Mar 31;18(7):3625. doi: 10.3390/ijerph18073625.

  PMID: 33807296 BACKGROUND

Related Links

• Ref. 2

MeSH Terms

Conditions

Agnosia; Nephrolithiasis

Interventions

Parapsychology; Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ayhan Şahin, Assoc. Prof.

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: February 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)