Obturator Nerve BlockNCT05652309
Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?
An observational study of Obturator Nerve Block and Ultrasound Guided Nerve Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obturator Nerve Block, Ultrasound Guided Nerve Block, Complications Neurological
- What is being tested?
- spinal block and obturator nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2023to Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who will undergo transurethral resection of the bladder
Who may be able to join
- age between 18-75
- ASA1, ASA2, ASA 3 physical status
Who cannot join
- The patient's refusal
- Active infection in the area to be blocked
- Kidney failure
- Liver failure
- Heart failure
- BMI less than 18 and a BMI greater than 40
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Serap Diker
Ankara, Çankaya
Serap Diker, MD, serap.diker@gmail.com
About this study
Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach
- Being tested
- spinal block and obturator nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal block and obturator nerve blockProcedure or surgery
spinal block and obturator nerve block
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | spinal block will be performed to patients after monitoring Receives: Procedure: spinal block and obturator nerve block | |
| spinal anesthesia and obturator nerve block | spinal block will be performed to patients after monitoring, and then the patients in the ONB block group will be given the appropriate position, with a USG-assisted distal approach, 5 cc %2 prilocain into the anterior and 5cc %2 prilocain into the posterior branch of the obturator nerve. Receives: Procedure: spinal block and obturator nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pin prick test
postoperatively sensation block
Measured: postoperatively 2nd hour
bromage score
motorial block
Measured: postoperatively 2nd hour
pin prick test
postoperatively sensation block
Measured: postoperatively 5th hour
bromage score
motorial block
Measured: postoperatively 5th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obturator Nerve BlockStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Diker, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652309
- Sponsor's protocol ID
- E2-22-1854
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?
- ClinicalTrials.gov ID
- NCT05652309
- Acronym / sponsor ID
- E2-22-1854
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Dec 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.
Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | – | Procedure: spinal block and obturator nerve blockspinal block will be performed to patients after monitoring |
| spinal anesthesia and obturator nerve block | – | Procedure: spinal block and obturator nerve blockspinal block will be performed to patients after monitoring, and then the patients in the ONB block group will be given the appropriate position, with a USG-assisted distal approach, 5 cc %2 prilocain into the anterior and 5cc %2 prilocain into the posterior branch of the obturator nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo transurethral resection of the bladder
Key inclusion criteria (2 listed)
- age between 18-75
- ASA1, ASA2, ASA 3 physical status
Key exclusion criteria (6 listed)
- The patient's refusal
- Active infection in the area to be blocked
- Kidney failure
- Liver failure
- Heart failure
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 |
|---|---|---|
| spinal block and obturator nerve blockspinal block and obturator nerve block | Procedure or surgery | spinal anesthesia, spinal anesthesia and obturator nerve block |
Primary outcome
pin prick test
Time frame: postoperatively 2nd hour
postoperatively sensation block
bromage score
Time frame: postoperatively 2nd hour
motorial block
pin prick test
Time frame: postoperatively 5th hour
postoperatively sensation block
bromage score
Time frame: postoperatively 5th hour
motorial block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obturator Nerve Block and Ultrasound Guided Nerve Block, run by Ankara City Hospital Bilkent 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 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: status not confirmed, as of the sponsor's last update on 15 Dec 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 serap diker, MD (+9031256600, serap.diker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pin prick test (time frame: postoperatively 2nd hour). The study lists 4 primary outcomes in all. 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 15 Dec 2022.