Pain, AcutePhase 4NCT03080363
Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL
A Phase 4 study testing Bupivacaine and Lidocaine in people with Pain, Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Bupivacaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 5 Jun 2017
- 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 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.
About this study
Official title: Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy
Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation.
Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream).
The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.
- Conditions
- Pain, Acute
- Being tested
- Bupivacaine, Lidocaine
- Keywords
- Extracorporeal Shockwave Lithotripsy, Quadratus Lumborum Block, bupivacaine, lidocaine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
10 ml %0.5 bupivacaine
LidocaineDrug
10 ml %2 lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Ultrasound guided Quadratus Lumborum Block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine Receives: Drug: Bupivacaine; Drug: Lidocaine |
| Group Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score
Visual Analog Pain Score at 5.,10.,15., 20., 25., 30. minutes
Measured: Intraoperative 30 minutes
Secondary outcomes (1)
Opioid consumption
Opioid consumption at 5.,10.,15., 20., 25., 30. minutes
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 posted15 Mar 2017
- Study start15 Mar 2017
- Primary completion15 May 2017
- Study completion5 Jun 2017
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 Pain, AcuteStudies 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
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
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
- NCT03080363
- Sponsor's protocol ID
- Ataturk University ESWL
- Status last verified
- Nov 2017
- First submitted
- 6 Mar 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elnabtity AM, Tawfeek MM, Keera AA, Badran YA. Is unilateral transversus abdominis plane block an analgesic alternative for ureteric shock wave lithotripsy? Anesth Essays Res. 2015 Jan-Apr;9(1):51-6. doi: 10.4103/0259-1162.150177.
PubMed 25886421Hanoura S, Elsayed M, Eldegwy M, Elsayed A, Ewieda T, Shehab M. Paravertebral block is a proper alternative anesthesia for outpatient lithotripsy. Anesth Essays Res. 2013 Sep-Dec;7(3):365-70. doi: 10.4103/0259-1162.123238.
PubMed 25885985
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy
- ClinicalTrials.gov ID
- NCT03080363
- Acronym / sponsor ID
- Ataturk University ESWL
- Conditions
- Pain, Acute
- Keywords
- Extracorporeal Shockwave Lithotripsy, Quadratus Lumborum Block, bupivacaine, lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 15 Mar 2017 (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 shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation.
Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream).
The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Drug: Bupivacaine, Drug: LidocaineUltrasound guided Quadratus Lumborum Block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine |
| Group Control | No intervention | –No intervention |
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 |
|---|---|---|
| Bupivacaine10 ml %0.5 bupivacaine | Drug | Quadratus Lumborum Block |
| Lidocaine10 ml %2 lidocaine | Drug | Quadratus Lumborum Block |
Primary outcome
Visual Analog Pain Score
Time frame: Intraoperative 30 minutes
Visual Analog Pain Score at 5.,10.,15., 20., 25., 30. minutes
1 secondary outcome
Opioid consumption
Time frame: Intraoperative 30 minutes
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 14 Nov 2017.
- Background: PubMed 25886421Elnabtity AM, Tawfeek MM, Keera AA, Badran YA. Is unilateral transversus abdominis plane block an analgesic alternative for ureteric shock wave lithotripsy? Anesth Essays Res. 2015 Jan-Apr;9(1):51-6. doi: 10.4103/0259-1162.150177.
- Background: PubMed 25885985Hanoura S, Elsayed M, Eldegwy M, Elsayed A, Ewieda T, Shehab M. Paravertebral block is a proper alternative anesthesia for outpatient lithotripsy. Anesth Essays Res. 2013 Sep-Dec;7(3):365-70. doi: 10.4103/0259-1162.123238.
- Individual participant dataSharing planned: Undecided
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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 Bupivacaine and Lidocaine in people with Pain, Acute, 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: finished, as of the sponsor's last update on 14 Nov 2017. 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?
Visual Analog Pain Score (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 NCT03080363, 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 14 Nov 2017.