Urinary System StonesNCT04213924
Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL
A study testing Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml and 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously in people with Urinary System Stones and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urinary System Stones, Pain
- What is being tested?
- Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml and 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Oct 2020
- 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
- American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy
Who cannot join
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University
Erzurum
Ahmet Murat Yayik, MD, 00905544259287, m_yayik@hotmail.com
About this study
Official title: The Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL
Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.
- Conditions
- Urinary System Stones, Pain
- Being tested
- Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml, 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously
- Keywords
- Extracorporeal Shockwave Lithotripsy, Erector Spinae Plane Block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 mlDrug
Erector spinae plane block, 30 min before the ESWL procedure.
5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenouslyDrug
5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB | Active comparator | Ultrasound-guided erector spinae plane block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine Receives: Drug: Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml |
| Group NSAII | Active comparator | lidocaine 5% gel and 800 mg ibuprofen intravenously Receives: Drug: 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Opioid consumption during procedure
Measured: Intraoperative 30 minutes
Secondary outcomes (1)
Visual Analog Pain Score
Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Measured: Intraoperative 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary System StonesStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213924
- Sponsor's protocol ID
- ESPB for ESWL
- Status last verified
- Jun 2020
- First submitted
- 27 Dec 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.
PubMed 31496381Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. No abstract available.
PubMed 29414615
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL
- ClinicalTrials.gov ID
- NCT04213924
- Acronym / sponsor ID
- ESPB for ESWL
- Conditions
- Urinary System Stones, Pain
- Keywords
- Extracorporeal Shockwave Lithotripsy, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESPB | Active comparator | Drug: Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 mlUltrasound-guided erector spinae plane block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine |
| Group NSAII | Active comparator | Drug: 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenouslylidocaine 5% gel and 800 mg ibuprofen intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy
Key exclusion criteria (5 listed)
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
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 |
|---|---|---|
| Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 mlErector spinae plane block, 30 min before the ESWL procedure. | Drug | Group ESPB |
| 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure. | Drug | Group NSAII |
Primary outcome
Opioid Consumption
Time frame: Intraoperative 30 minutes
Opioid consumption during procedure
1 secondary outcome
Visual Analog Pain Score
Time frame: Intraoperative 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 31496381Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.
- Background: PubMed 29414615Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml and 5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously in people with Urinary System Stones and Pain, run by Ataturk 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 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Yayik, MD (00905544259287, m_yayik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: Intraoperative 30 minutes). 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 NCT04213924, which also lists 2 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 4 Jun 2020.