Renal ColicPhase 4NCT04209439
Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain
A Phase 4 study testing 30 ml %0.25 bupivacaine and Dexketoprofen-trometamol in people with Renal Colic, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- 30 ml %0.25 bupivacaine and Dexketoprofen-trometamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 28 Jan 2020
- Phase
- Phase 4
- 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
Who cannot join
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study
Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves.
The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.
- Conditions
- Renal Colic
- Being tested
- 30 ml %0.25 bupivacaine, Dexketoprofen-trometamol
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 ml %0.25 bupivacaineDrug
Ultrasound-guided erector spinae plane block
Dexketoprofen-trometamolDrug
50 mg Dexketoprofen-trometamol intravenous
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided erector spinae plane block | Active comparator | 30 ml %0.25 ultrasound-guided erector spinae plane block at the level of T8 Receives: Drug: 30 ml %0.25 bupivacaine |
| Dexketoprofen-trometamol | Active comparator | intravenous 50 mg dexketoprofen-trometamol Receives: Drug: Dexketoprofen-trometamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of analgesic consumption
Fentanyl
Measured: 1 hour
Secondary outcomes (1)
Numeric Rating Scale
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. NRS score will be recorded after intervention at 5.,10.,15.,30.,45. and 60. minute
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion28 Jan 2020
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 Renal ColicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209439
- Sponsor's protocol ID
- AUTF ANESTHESIAEMERGENCY
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin ME, Ahiskalioglu A, Tekin E, Ozkaya F, Ahiskalioglu EO, Bayramoglu A. Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. Am J Emerg Med. 2019 Apr;37(4):794.e1-794.e3. doi: 10.1016/j.ajem.2018.12.042. Epub 2018 Dec 23.
PubMed 30595427Yayik 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 31496381Forero 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 27501016
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04209439
- Acronym / sponsor ID
- AUTF ANESTHESIAEMERGENCY
- Conditions
- Renal Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 24 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.
Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves.
The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided erector spinae plane block | Active comparator | Drug: 30 ml %0.25 bupivacaine30 ml %0.25 ultrasound-guided erector spinae plane block at the level of T8 |
| Dexketoprofen-trometamol | Active comparator | Drug: Dexketoprofen-trometamolintravenous 50 mg dexketoprofen-trometamol |
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
Key exclusion criteria (4 listed)
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
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 |
|---|---|---|
| 30 ml %0.25 bupivacaineUltrasound-guided erector spinae plane block | Drug | ultrasound guided erector spinae plane block |
| Dexketoprofen-trometamol50 mg Dexketoprofen-trometamol intravenous | Drug | Dexketoprofen-trometamol |
Primary outcome
Number of analgesic consumption
Time frame: 1 hour
Fentanyl
1 secondary outcome
Numeric Rating Scale
Time frame: 1 hour
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 29 Jan 2020.
- Background: PubMed 30595427Aydin ME, Ahiskalioglu A, Tekin E, Ozkaya F, Ahiskalioglu EO, Bayramoglu A. Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. Am J Emerg Med. 2019 Apr;37(4):794.e1-794.e3. doi: 10.1016/j.ajem.2018.12.042. Epub 2018 Dec 23.
- 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 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 30 ml %0.25 bupivacaine and Dexketoprofen-trometamol in people with Renal Colic, 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 4 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 29 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of analgesic consumption (time frame: 1 hour). 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 NCT04209439, 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 29 Jan 2020.