Acute Postoperative Pain in Urological SurgeryNCT07672600
The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy
A study testing Erector Spinae Plane Block and Intravenous analgesia in people with Acute Postoperative Pain in Urological Surgery and Regional Anaesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Postoperative Pain in Urological Surgery, Regional Anaesthesia
- What is being tested?
- Erector Spinae Plane Block and Intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective percutaneous nephrolitotomy
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- Refusal to participate
- Coagulopathy,
- Infection at the block site
- Allergy to local anaesthetics
- Previous surgery in the block area
- Severe systemic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Being tested
- Erector Spinae Plane Block, Intravenous analgesia
- Keywords
- Erector spinae plane block, percutaneous nephrolithotomy, postoperative analgesia, regional anaesthesia, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector spinae plane block is applied in longitudinal plane at T9 level.
Intravenous analgesiaProcedure or surgery
Inravenous morphine is administered via patient controlled analgesia device.
| Study group | Role | What they receive |
|---|---|---|
| Group erector spinae plane block (Group ESPB) | Active comparator | Patients received erector spinae plane block for postoperative analgesia Receives: Procedure: Erector Spinae Plane Block |
| Group Control (Group C) | Active comparator | Patients received only intravenous analgesia Receives: Procedure: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24-hour morphine consumption
Total 24-hour intravenous morphine consumption via patient controlled analgesia device
Measured: 24 hours
Secondary outcomes (10)
Pain assessment
Pain assessment is evaluated using numeric rating scale (NRS 0-10; 0: no pain, 10: the worst pain imaginable)
Measured: 24 hours
Additional analgesic requirement
If the Numeric Rating Scale (NRS) score exceeded 4, rescue analgesia consisted of additional morphine 0.02 mg/kg, plus intravenous paracetamol 1 g.
Measured: 24 hours
Postoperative nausea and vomiting
Number of patients experienced postoperative nausea and vomiting .
Measured: 24 hours
Patient satisfaction
Patient satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)
Measured: Up to 24 hours
Surgeon satisfaction
Surgeon satisfaction is questioned using Likert scale:1-3 (1: dissatisfied, 2: neutral, 3: satisfied)
Measured: Up to 24 hours
First rescue analgesic time
The first time patient required rescue analgesic
Measured: 24 hours
Length of hospital stay
Length of hospital stay
Measured: Up to 1 week
Chronic pain
Chronic pain is evaluated using NRS scores
Measured: 3 months
Pruritus
The number of patients experienced pruritus
Measured: 24 hours
Chronic pain
Chronic pain is evaluated using DN4 questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Oct 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative Pain in Urological SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Momunat Dadashova, MD, Principal investigator, Liv Hospital Vadi Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672600
- Sponsor's protocol ID
- 2019/177
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy: a Randomised Single-blind Trial
- ClinicalTrials.gov ID
- NCT07672600
- Acronym / sponsor ID
- 2019/177
- Keywords
- Erector spinae plane block, percutaneous nephrolithotomy, postoperative analgesia, regional anaesthesia, morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, prospective
| Arm | Type | Receives |
|---|---|---|
| Group erector spinae plane block (Group ESPB) | Active comparator | Procedure: Erector Spinae Plane BlockPatients received erector spinae plane block for postoperative analgesia |
| Group Control (Group C) | Active comparator | Procedure: Intravenous analgesiaPatients received only intravenous analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective percutaneous nephrolitotomy
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (6 listed)
- Refusal to participate
- Coagulopathy,
- Infection at the block site
- Allergy to local anaesthetics
- Previous surgery in the block area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockErector spinae plane block is applied in longitudinal plane at T9 level. | Procedure or surgery | Group erector spinae plane block (Group ESPB) |
| Intravenous analgesiaInravenous morphine is administered via patient controlled analgesia device. | Procedure or surgery | Group Control (Group C) |
Primary outcome
Total 24-hour morphine consumption
Time frame: 24 hours
Total 24-hour intravenous morphine consumption via patient controlled analgesia device
10 secondary outcomes
Pain assessment
Time frame: 24 hours
Additional analgesic requirement
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Patient satisfaction
Time frame: Up to 24 hours
Surgeon satisfaction
Time frame: Up to 24 hours
First rescue analgesic time
Time frame: 24 hours
Length of hospital stay
Time frame: Up to 1 week
Chronic pain
Time frame: 3 months
Pruritus
Time frame: 24 hours
Chronic pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momunat Dadashova, MD principal investigator
Liv Hospital Vadi Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Intravenous analgesia in people with Acute Postoperative Pain in Urological Surgery and Regional Anaesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24-hour morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.