Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and MortalityNCT04995445
Retrospective Evaluation of the Effect of Ultrasound-guided Obturator Nerve Block on Complications in Transurethral (TUR-M) Resection Surgery for Bladder Side Wall Tumors.
An observational study of Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and Mortality, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effectiveness of obturator nerve block added to spinal anesthesia in the operation of transurethral resection (TUR-M) of bladder lateral-infrolateral wall tumors on the obturator reflex and related complications was investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and Mortality
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2019to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: more than 18 years regional anesthesia method was applied The files of patients who underwent Tur-M surgery were reviewed retrospectively.
Who may be able to join
- Patients over the age of 18 who have undergone bladder tumor surgery and whose anesthesia method is spinal anesthesia
Who cannot join
- under 18 years old , received general anesthesia pregnant and pediatric patient data not used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çorum training and research state hospital
Çorum, 19030
About this study
In this study, the effectiveness of obturator nerve block added to spinal anesthesia in the operation of transurethral resection (TUR-M) of bladder lateral-infrolateral wall tumors on the obturator reflex and related complications was investigated.
- Keywords
- Obturator nerve block, complications of transurethral resection, TUR-M
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer
patient who underwent spinal anesthesia and obturator block
Measured: 2 year
Secondary outcomes (1)
Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer
The patient group who underwent spinal anesthesia and obturator block and the group without obturator block
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start26 Apr 2019
- Primary completion20 Jan 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and MortalityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HULYA TOPCU, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995445
- Sponsor's protocol ID
- 2019-158
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Effect of Ultrasound-guided Obturator Nerve Block on Complications in Transurethral (TUR-M) Resection Surgery for Bladder Side Wall Tumors.
- ClinicalTrials.gov ID
- NCT04995445
- Acronym / sponsor ID
- 2019-158
- Keywords
- Obturator nerve block, complications of transurethral resection, TUR-M
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Aug 2021 (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.
In this study, the effectiveness of obturator nerve block added to spinal anesthesia in the operation of transurethral resection (TUR-M) of bladder lateral-infrolateral wall tumors on the obturator reflex and related complications was investigated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- more than 18 years regional anesthesia method was applied The files of patients who underwent Tur-M surgery were reviewed retrospectively.
Key inclusion criteria (1 listed)
- Patients over the age of 18 who have undergone bladder tumor surgery and whose anesthesia method is spinal anesthesia
Key exclusion criteria (1 listed)
- under 18 years old , received general anesthesia pregnant and pediatric patient data not used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer
Time frame: 2 year
patient who underwent spinal anesthesia and obturator block
1 secondary outcome
Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer
Time frame: 2 year
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 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and Mortality, run by Erol Olcok Corum Training 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 1 inclusion and 1 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 9 Aug 2021. 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?
Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer (time frame: 2 year). 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 9 Aug 2021.