- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672600
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
Keywords
Other Study ID Numbers
- 2019/177
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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