AnalgesiaESPURSNCT06826833
ESP Block for Postoperative Analgesia in URS Surgery
A study testing Erector Spinae Plane (ESP) Block in people with Analgesia and Postoperative Pain Management, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Postoperative Pain Management, Nephrolithiasis
- What is being tested?
- Erector Spinae Plane (ESP) Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 20 Aug 2025
- 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
- Patients undergoing elective flexible ureterorenoscopy (URS).
- Age: 18-65 years.
- ASA I-II.
- Willing to participate and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Namık Kemal University Research Hospital
Tekirdağ, 59000
About this study
Official title: Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial
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?
Read more
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.
Read the detailed description
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).
- Conditions
- Analgesia, Postoperative Pain Management, Nephrolithiasis
- Being tested
- Erector Spinae Plane (ESP) Block
- Medical subject headings
- Agnosia, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Erector Spinae Plane (ESP) Block |
| Control Group | No intervention | Patients will receive routine multimodal analgesia without an ESP block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 2, 6, 12, 24 hours postoperatively.
Secondary outcomes (3)
Total Opioid Consumption (IV PCA Morphine Equivalent)
Description: Total opioid consumption will be recorded in morphine milligram equivalents (MME) administered via IV patient-controlled analgesia (PCA).
Measured: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.
Postoperative Nausea and Vomiting (PONV)
The incidence of postoperative nausea and vomiting (PONV) will be recorded, defined as nausea and/or vomiting requiring treatment with ondansetron IV.
Measured: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.
Pain-Free Duration
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).
Measured: From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Feb 2025
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Baran, Namik Kemal University
- Investigators
- Ayhan Şahin, Assoc. Prof., Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826833
- Sponsor's protocol ID
- TNKU-URS001
- Acronym
- ESPURS
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27501016Bryniarski 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.
PubMed 33807296Sahin A, Baran O, Dogan C, Sahin MF, Arar C. Erector spinae plane block for postoperative analgesia in patients undergoing flexible ureteroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 May 13;26(1):401. doi: 10.1186/s12871-026-03884-y.
PubMed 42121081
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06826833
- Acronym / sponsor ID
- ESPURS / TNKU-URS001
- Conditions
- Analgesia, Postoperative Pain Management, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 14 Feb 2025 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Block Group | Experimental | Procedure: Erector Spinae Plane (ESP) BlockA 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. |
| Control Group | No intervention | –Patients will receive routine multimodal analgesia without an ESP block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective flexible ureterorenoscopy (URS).
- Age: 18-65 years.
- ASA I-II.
- Willing to participate and provide written informed consent.
Key exclusion criteria (5 listed)
- 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.
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 (ESP) BlockA 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 or surgery | ESP Block Group |
Primary outcome
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
3 secondary outcomes
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.
Postoperative Nausea and Vomiting (PONV)
Time frame: From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.
Pain-Free Duration
Time frame: From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.
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 19 Feb 2026.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 33807296Bryniarski 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.
- Derived from this study: PubMed 42121081Sahin A, Baran O, Dogan C, Sahin MF, Arar C. Erector spinae plane block for postoperative analgesia in patients undergoing flexible ureteroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 May 13;26(1):401. doi: 10.1186/s12871-026-03884-y.
- Ref. 2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ayhan Şahin, Assoc. Prof. principal investigator
Namik Kemal University
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 (ESP) Block in people with Analgesia and Postoperative Pain Management, run by Namik Kemal 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 4 inclusion and 5 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 19 Feb 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?
Pain Intensity (Numeric Rating Scale - NRS) (time frame: 0, 2, 6, 12, 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06826833, which also lists 3 linked publications.
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 19 Feb 2026.