Bladder NeoplasmNCT05540847
Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
A study testing Interfascial Injection and Subpectineal Injection in people with Bladder Neoplasm, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasm
- What is being tested?
- Interfascial Injection and Subpectineal Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2022to 23 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lateral wall bladder tumour
- ASA I-II patients
Who cannot join
- Contraindications for spinal anesthesia,
- Tumors that disrupt the integrity of the bladder,
- Coagulation disorders,
- Uncooperative patients,
- Allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
Yenimahalle, Ankara, 06170
About this study
This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.
- Conditions
- Bladder Neoplasm
- Being tested
- Interfascial Injection, Subpectineal Injection
- Keywords
- obturator nerve block, ultrasound guided block, bladder tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interfascial InjectionProcedure or surgery
Interfascial Injection on Ultrasound-guided Obturator Nerve Block
Subpectineal InjectionProcedure or surgery
Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided interfascial obturator nerve block | Active comparator | In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance. Receives: Procedure: Interfascial Injection |
| Ultrasound guided subpectineal obturator nerve block | Experimental | In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance. Receives: Procedure: Subpectineal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of obturatr nerve block
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.
Measured: Peroperative period
Secondary outcomes (4)
Number of adductor muscle spazms
Number of adductor muscle spazms in each group will be noted during the intraoperative period.
Measured: Intraoperative period
Sensory block
Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches.
Measured: 30 minutes after the intervention
Patient satisfaction
Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied
Measured: Peroperative period
Procedure time
Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start16 Sep 2022
- Primary completion1 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder NeoplasmStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Cihan Kose, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540847
- Sponsor's protocol ID
- 141/09
- Status last verified
- Apr 2023
- First submitted
- 12 Sep 2022
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
- ClinicalTrials.gov ID
- NCT05540847
- Acronym / sponsor ID
- 141/09
- Conditions
- Bladder Neoplasm
- Keywords
- obturator nerve block, ultrasound guided block, bladder tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 15 Sep 2022 (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.
This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided interfascial obturator nerve block | Active comparator | Procedure: Interfascial InjectionIn supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance. |
| Ultrasound guided subpectineal obturator nerve block | Experimental | Procedure: Subpectineal InjectionIn supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lateral wall bladder tumour
- ASA I-II patients
Key exclusion criteria (5 listed)
- Contraindications for spinal anesthesia,
- Tumors that disrupt the integrity of the bladder,
- Coagulation disorders,
- Uncooperative patients,
- Allergy to local anesthetics.
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 |
|---|---|---|
| Interfascial InjectionInterfascial Injection on Ultrasound-guided Obturator Nerve Block | Procedure or surgery | Ultrasound guided interfascial obturator nerve block |
| Subpectineal InjectionSubpectineal Injection on Ultrasound-guided Obturator Nerve Block | Procedure or surgery | Ultrasound guided subpectineal obturator nerve block |
Primary outcome
Success rate of obturatr nerve block
Time frame: Peroperative period
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.
4 secondary outcomes
Number of adductor muscle spazms
Time frame: Intraoperative period
Sensory block
Time frame: 30 minutes after the intervention
Patient satisfaction
Time frame: Peroperative period
Procedure time
Time frame: During the procedure
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 25 Apr 2023.
- 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 study testing Interfascial Injection and Subpectineal Injection in people with Bladder Neoplasm, run by Diskapi Teaching and Research Hospital 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 2 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 25 Apr 2023. 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?
Success rate of obturatr nerve block (time frame: Peroperative period). 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 25 Apr 2023.