Succesful Obturator Nerve BlockNCT04638569
Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs
A study testing obturator nerve block in people with Succesful Obturator Nerve Block and Bladder Tumor, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Succesful Obturator Nerve Block, Bladder Tumor, Bleeding
- What is being tested?
- obturator nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2021to 1 Sep 2022
- 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
- ASA I-II patients
Who cannot join
- Tumors that disrupt the integrity of the bladder,
- bladder floor tumors,
- coagulation disorders,
- motor in the lower limbs
- with sensory disturbances,
- uncooperative patients,
- Known allergy to local anesthetics
- patients with localized infection at the procedure site
Trial locations and contacts
1 site in 1 country.
eylem yasar contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mugla Sitki Kocman University
Muğla, 48000
Eylem Yaşar, MD, 00905332392622, eylemtarakci@gmail.com
About this study
Official title: Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection
Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.
Read the detailed description
The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.
- Conditions
- Succesful Obturator Nerve Block, Bladder Tumor, Bleeding
- Being tested
- obturator nerve block
- Keywords
- obturator nerve block, bladder tumor, ultrasonografi, anatomical signs
- Medical subject headings
- Urinary Bladder Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturator nerve blockProcedure or surgery
The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. The time elapsed until the first needle insertion and local anesthetic injection is completed will be recorded as the application time.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided obturator nerve block group | Active comparator | The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. Receives: Procedure: obturator nerve block |
| obtutaror nerve block with anatomical landmarks | Active comparator | In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. Receives: Procedure: obturator nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative succesful obturator nerve block
peroperative adductor muscle spazm
Measured: operation time
Secondary outcomes (1)
peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month
peroperative bledding, Control by cystoscopy in the postoperative 3rd month recurrence tumor size
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Feb 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Succesful Obturator Nerve BlockStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 116 participants (estimated)
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 Yaşar, Principal investigator, Muğla Sıtkı Koçman UniversityAli İhsan Uysal, Study chair, Mugla Sitki Kocman University Department of Anesthesiaİlker Akarken, Study chair, Mugla Sitki Kocman University Department of Urologybasak altiparmak, Study chair, Mugla Sitki Kocman University Department of Anesthesiasemra demirbilek, Study chair, Mugla Sitki Kocman University Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638569
- Sponsor's protocol ID
- 27/12/2019-19/VIII
- Status last verified
- Jan 2022
- First submitted
- 16 Nov 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection
- ClinicalTrials.gov ID
- NCT04638569
- Acronym / sponsor ID
- 27/12/2019-19/VIII
- Conditions
- Succesful Obturator Nerve Block, Bladder Tumor, Bleeding
- Keywords
- obturator nerve block, bladder tumor, ultrasonografi, anatomical signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 20 Nov 2020 (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.
Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.
Detailed description
The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided obturator nerve block group | Active comparator | Procedure: obturator nerve blockThe ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. |
| obtutaror nerve block with anatomical landmarks | Active comparator | Procedure: obturator nerve blockIn the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients
Key exclusion criteria (8 listed)
- Tumors that disrupt the integrity of the bladder,
- bladder floor tumors,
- coagulation disorders,
- motor in the lower limbs
- with sensory disturbances,
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 |
|---|---|---|
| obturator nerve blockThe ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. The time elapsed until the first needle insertion and local anesthetic injection is completed will be recorded as the application time. | Procedure or surgery | Ultrasound-guided obturator nerve block group, obtutaror nerve block with anatomical landmarks |
Primary outcome
Preoperative succesful obturator nerve block
Time frame: operation time
peroperative adductor muscle spazm
1 secondary outcome
peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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 contact
Eylem Yaşar principal investigator
Muğla Sıtkı Koçman University
Ali İhsan Uysal study chair
Mugla Sitki Kocman University Department of Anesthesia
İlker Akarken study chair
Mugla Sitki Kocman University Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing obturator nerve block in people with Succesful Obturator Nerve Block and Bladder Tumor, 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 1 inclusion and 8 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 7 Feb 2022. 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 Eylem Yasar, MD (00905332392622, eylemtarakci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative succesful obturator nerve block (time frame: operation time). 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 7 Feb 2022.