Lower Urinary Tract SymptomsNCT06290323
Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms
A study testing Quadratus lumborum block in people with Lower Urinary Tract Symptoms, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The most common reason for applying to a hospital in the postoperative period is due to the double J stent inserted during operations of the ureteroscopic lithotripsy, which is reflected pain (T11-L2). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 4 Oct 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral URS planned to be applied
- DJS is planned to be inserted due to unilateral stone size of 5-15 mm.
- ASA I-II-III patients
Who cannot join
- Patients with bilateral ureteral stones,
- Patients with >15 mm or <5 mm ureteral stones,
- Patients with known paracetamol allergy,
- Patients with any contraindications to the regional technique
- Patients with chronic analgesic use
- Patients with a body mass index over 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman Training and Research Hospital
Muğla, 48000
About this study
Official title: Effects of Postoperative Quadratus Lumborum Block on Sub-Urine System Symptoms in Ureteroscopic Lithotripsy Operations: Randomized Controlled Study
The most common reason for applying to a hospital in the postoperative period is due to the double J stent inserted during operations of the ureteroscopic lithotripsy, which is reflected pain (T11-L2). The posterior approximation QL block (QL-P) extends more quickly to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by the 'Ureteral Stent Symptom Scoring Survey.' QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia.
Read the detailed description
All patients will be seated to apply spinal anesthetic. Patients will be inserted into the interspinal space using a 25-gauge Quincke needle from the lumbar (L) 3-L4 spinal interval or the L4-L5 spinal interval, thereby inducing a sensory block at a 0.5% hyperbaric bupivacaine level with a Trocal (T) 10. Once a T-10 level sensory block has been established, the patients will be separated into two groups. As the control group, the individuals comprising Group 1 will be positioned in the lithotomy position after the sensory block for the surgical procedure. Group 2 patients will be placed in lateral decubitus to conduct a quadratus lumborum block. Once the skin's surface has been sterilized, the convex ultrasound probe (SonoSiteMTurbo; FUJIFILM SonoSite, Bothell, WA) will be moved laterally to the lateral to visualize the psoas and quadratus lumborum muscles. The probe will be inserted perpendicular to the spine in the 12th vertebral body. The in-plane method with the lateral of the probe 22 gauge needle, between the quadratus lumborum muscle and the front layer of the thoracolumbar fascia after the position accuracy is determined with 1-2 mL serum physiologic, %0.375 Mg of bupivacaine will be injected in 20 ml. The patient will then be placed in the lithotomy position for the surgical procedure. Patients of a blind research assistant to the group distribution are seen on-site in the 1st, 6th, 12th, and 24th hours after surgery, postoperative 7. Per phone daily, pain intensities will be assessed by a 'numerical assessment scale' (Numeric Rating Scala: NRS). If NRS is above 3 for half an hour, 100 mg tramadol will be added. For 48 hours, tramadol and non-steroidal anti-inflammatory consumption will be monitored. In addition, complications such as local anesthesia toxicity, allergy, internal organ injury, postoperative nausea and vomiting, and postoperative bleeding will be recorded. In addition, on the 7th post-operative day, the patient's pain level will be evaluated with NRS, and the sub-productive system symptoms connected to DJS are assessed with the ureteral stent symptom scoring questionnaire (while inserted in the stent). In our clinic, approximately one month after URS operations, a control cystoscopy is performed, and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent symptom scoring questionnaire (after the stent is removed).
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Quadratus lumborum block, Placebo
- Keywords
- Lithotripsy, Lower Urinary Tract Symptoms, Pain
- Medical subject headings
- Lower Urinary Tract Symptoms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
Posterior quadratus lumborum block
PlaceboProcedure or surgery
Patients in the first group are the control group and after spinal anesthesia, the sensory block is formed, the lithotomy position will be taken for the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Other | Patients in the first group are the control group, and after spinal anesthesia, the sensory block is formed, and the lithotomy position will be taken for the surgical procedure. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS, and the DJS-connected sub-urinary system symptoms assessed will be evaluated with the ureteral stent discomfort questionnaire (with the stent inserted). In our clinic, approximately one month after URS operations, control cystoscopy is performed and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent discomfort questionnaire (after removal of the stent). Receives: Procedure: Placebo |
| Quadratus lumborum | Active comparator | After the posterior quadratus lumborum block was made in the lateral decubitus position, the patient was taken to the lithotomy position for surgery. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS and the DJS-connected sub-urinary system symptoms will be assessed and evaluated using the ureteral stent discomfort questionnaire (with the stent inserted). In our clinic, approximately one month after URS operations, a control cystoscopy is performed, and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent discomfort questionnaire (after removal of the stent). Receives: Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadratus posterior block
On the 7th post-operative day, lower urinary tract symptoms due to the ureteral stent will be evaluated with the ureteral stent symptom scoring questionnaire (with the stent in place) (questionnaire 1).
Approximately one month after their operations, patients' lower urinary tract symptoms will be questioned withent symptom scoring survey (after stent removal) (survey 2) (Appendix 2) five the ureteral st days after their ureteral stents are removed.
Measured: 1 month
Secondary outcomes (1)
Pain Score
To evaluate the patients' postoperative pain scores (7 days) using the Numerical Rating Scale. If NRS is above 3 for half an hour, 100 mg tramadol will be added.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start25 Jan 2024
- Primary completion1 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Yaşar, Muğla Sıtkı Koçman University
- Investigators
- Eylem Yasar, MD, Principal investigator, Mugla Sitki Kocman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290323
- Sponsor's protocol ID
- 11/05/2022-9/VIII
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If any organization asks for our study data, we may share our data without revealing the identities of the patients.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postoperative Quadratus Lumborum Block on Sub-Urine System Symptoms in Ureteroscopic Lithotripsy Operations: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06290323
- Acronym / sponsor ID
- 11/05/2022-9/VIII
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lithotripsy, Lower Urinary Tract Symptoms, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 4 Mar 2024 (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 most common reason for applying to a hospital in the postoperative period is due to the double J stent inserted during operations of the ureteroscopic lithotripsy, which is reflected pain (T11-L2). The posterior approximation QL block (QL-P) extends more quickly to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by the 'Ureteral Stent Symptom Scoring Survey.' QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia.
Detailed description
All patients will be seated to apply spinal anesthetic. Patients will be inserted into the interspinal space using a 25-gauge Quincke needle from the lumbar (L) 3-L4 spinal interval or the L4-L5 spinal interval, thereby inducing a sensory block at a 0.5% hyperbaric bupivacaine level with a Trocal (T) 10. Once a T-10 level sensory block has been established, the patients will be separated into two groups. As the control group, the individuals comprising Group 1 will be positioned in the lithotomy position after the sensory block for the surgical procedure. Group 2 patients will be placed in lateral decubitus to conduct a quadratus lumborum block. Once the skin's surface has been sterilized, the convex ultrasound probe (SonoSiteMTurbo; FUJIFILM SonoSite, Bothell, WA) will be moved laterally to the lateral to visualize the psoas and quadratus lumborum muscles. The probe will be inserted perpendicular to the spine in the 12th vertebral body. The in-plane method with the lateral of the probe 22 gauge needle, between the quadratus lumborum muscle and the front layer of the thoracolumbar fascia after the position accuracy is determined with 1-2 mL serum physiologic, %0.375 Mg of bupivacaine will be injected in 20 ml. The patient will then be placed in the lithotomy position for the surgical procedure. Patients of a blind research assistant to the group distribution are seen on-site in the 1st, 6th, 12th, and 24th hours after surgery, postoperative 7. Per phone daily, pain intensities will be assessed by a 'numerical assessment scale' (Numeric Rating Scala: NRS). If NRS is above 3 for half an hour, 100 mg tramadol will be added. For 48 hours, tramadol and non-steroidal anti-inflammatory consumption will be monitored. In addition, complications such as local anesthesia toxicity, allergy, internal organ injury, postoperative nausea and vomiting, and postoperative bleeding will be recorded. In addition, on the 7th post-operative day, the patient's pain level will be evaluated with NRS, and the sub-productive system symptoms connected to DJS are assessed with the ureteral stent symptom scoring questionnaire (while inserted in the stent). In our clinic, approximately one month after URS operations, a control cystoscopy is performed, and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent symptom scoring questionnaire (after the stent is removed).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones
| Arm | Type | Receives |
|---|---|---|
| Placebo | Other | Procedure: PlaceboPatients in the first group are the control group, and after spinal anesthesia, the sensory block is formed, and the lithotomy position will be taken for the surgical procedure. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS, and the DJS-connected sub-urinary system symptoms assessed will be evaluated with the ureteral stent discomfort questionnaire (with the stent inserted). In our clinic, approximately one month after URS operations, control cystoscopy is performed and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent discomfort questionnaire (after removal of the stent). |
| Quadratus lumborum | Active comparator | Procedure: Quadratus lumborum blockAfter the posterior quadratus lumborum block was made in the lateral decubitus position, the patient was taken to the lithotomy position for surgery. Patients will be monitored for 48 hours for postoperative pain (Numarating Raiting Scala: NRS) and side effects. On the postoperative 7th day, the patient's pain level will be NRS and the DJS-connected sub-urinary system symptoms will be assessed and evaluated using the ureteral stent discomfort questionnaire (with the stent inserted). In our clinic, approximately one month after URS operations, a control cystoscopy is performed, and ureteral stents are removed. After five days of removal of the ureteral stent, the lower urinary system symptoms will be questioned with the ureteral stent discomfort questionnaire (after removal of the stent). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral URS planned to be applied
- DJS is planned to be inserted due to unilateral stone size of 5-15 mm.
- ASA I-II-III patients
Key exclusion criteria (6 listed)
- Patients with bilateral ureteral stones,
- Patients with >15 mm or <5 mm ureteral stones,
- Patients with known paracetamol allergy,
- Patients with any contraindications to the regional technique
- Patients with chronic analgesic use
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 |
|---|---|---|
| Quadratus lumborum blockPosterior quadratus lumborum block | Procedure or surgery | Quadratus lumborum |
| PlaceboPatients in the first group are the control group and after spinal anesthesia, the sensory block is formed, the lithotomy position will be taken for the surgical procedure. | Procedure or surgery | Placebo |
Primary outcome
Quadratus posterior block
Time frame: 1 month
On the 7th post-operative day, lower urinary tract symptoms due to the ureteral stent will be evaluated with the ureteral stent symptom scoring questionnaire (with the stent in place) (questionnaire 1). Approximately one month after their operations, patients' lower urinary tract symptoms will be questioned withent symptom scoring survey (after stent removal) (survey 2) (Appendix 2) five the ureteral st days after their ureteral stents are removed.
1 secondary outcome
Pain Score
Time frame: 7 days
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 5 Nov 2024.
- Individual participant dataSharing planned: No. If any organization asks for our study data, we may share our data without revealing the identities of the patients.
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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.
Eylem Yasar, MD principal investigator
Mugla Sitki Kocman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block in people with Lower Urinary Tract Symptoms, run by Muğla Sıtkı Koçman 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 3 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 5 Nov 2024. 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?
Quadratus posterior block (time frame: 1 month). 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 5 Nov 2024.