The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy

June 23, 2026 updated by: Meltem Savran Karadeniz, Istanbul University

The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy: a Randomised Single-blind Trial

This study is planned as a single-center randomized single blinded study and includes patients undergoing percutaneous nephrolitotomy.The aim of the study is to evaluate the effect of ultrasound guided erector spinal plane block on postoperative analgesia in percutaneous nephrolitotomy. Primary outcome is the total 24 hour morphine consumption.

Study Overview

Detailed Description

Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective PCNL were allocated to receive either a unilateral ultrasound-guided ESPB at the T9 level with 20 mL of 0.25% bupivacaine followed by postoperative IV morphine PCA (Group ESPB ) or postoperative IV morphine PCA alone (Group C). 24 hour morphine consumption, numeric Rating Scale (NRS) pain scores, rescue analgesic requirements, sedation scores, opioid-related adverse effects, hospital stay, chronic pain, patient and surgeon satisfaction are recorded.

Study Type

Interventional

Enrollment (Actual)

56

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 Locations

    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Istanbul University, Istanbul Faculty of Medicine

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:

  • Elective percutaneous nephrolitotomy
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

  • Refusal to participate
  • Coagulopathy,
  • Infection at the block site
  • Allergy to local anaesthetics
  • Previous surgery in the block area
  • Severe systemic disease.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group erector spinae plane block (Group ESPB)
Patients received erector spinae plane block for postoperative analgesia
Erector spinae plane block is applied in longitudinal plane at T9 level.
Active Comparator: Group Control (Group C)
Patients received only intravenous analgesia
Inravenous morphine is administered via patient controlled analgesia device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 24-hour morphine consumption
Time Frame: 24 hours
Total 24-hour intravenous morphine consumption via patient controlled analgesia device
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Up to 1 week
Length of hospital stay
Up to 1 week
Pain assessment
Time Frame: 24 hours
Pain assessment is evaluated using numeric rating scale (NRS 0-10; 0: no pain, 10: the worst pain imaginable)
24 hours
Additional analgesic requirement
Time Frame: 24 hours
If the Numeric Rating Scale (NRS) score exceeded 4, rescue analgesia consisted of additional morphine 0.02 mg/kg, plus intravenous paracetamol 1 g.
24 hours
Postoperative nausea and vomiting
Time Frame: 24 hours
Number of patients experienced postoperative nausea and vomiting .
24 hours
Patient satisfaction
Time Frame: Up to 24 hours
Patient satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)
Up to 24 hours
Surgeon satisfaction
Time Frame: Up to 24 hours
Surgeon satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)
Up to 24 hours
First rescue analgesic time
Time Frame: 24 hours
The first time patient required rescue analgesic
24 hours
Chronic pain
Time Frame: 3 months
Chronic pain is evaluated using NRS scores and DN4 questionnaire
3 months
Pruritus
Time Frame: 24 hours
The number of patients experienced pruritus
24 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Momunat Dadashova, MD, Liv Hospital Vadi Istanbul

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 (Actual)

October 1, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

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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