Obturator ReflexNCT07922941
Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block for Prevention of Obturator Reflex
A study testing Obturator Nerve Block, Femoral Nerve Block and Sciatic Nerve Block in people with Obturator Reflex, run by Tuna Erturk at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized controlled study aims to evaluate whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral resection of bladder tumors under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obturator Reflex
- What is being tested?
- Obturator Nerve Block, Femoral Nerve Block and Sciatic Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-90 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for transurethral resection of unilateral lateral or inferolateral bladder wall tumors under spinal anesthesia.
- Patients providing informed consent personally or through a legally authorized representative.
- No known hypersensitivity to the medications used in the study.
- No infection or anatomical deformity at the nerve block sites.
- No antithrombotic treatment and normal coagulation parameters.
Who cannot join
- Age younger than 18 or older than 90 years.
- ASA physical status IV or higher.
- Absence of informed consent.
- Hypersensitivity to the study medications or their components.
- Infection or anatomical deformity at the nerve block sites.
- Antithrombotic treatment.
- Abnormal coagulation parameters.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, 34668
Hakan EMİRKADI, MD, +905322609367, hemirkadi@gmail.com
About this study
Official title: Comparison of the Efficacy of Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block in Preventing the Obturator Reflex
This prospective, randomized controlled study aims to evaluate whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral resection of bladder tumors under spinal anesthesia.
Ninety patients will be randomly assigned to three groups: obturator nerve block alone, obturator plus femoral nerve blocks, or obturator plus femoral and sciatic nerve blocks. Adductor muscle contractions, surgeon satisfaction, procedure duration, and complications will be evaluated.
Read the detailed description
This single-center, prospective, randomized controlled study will include 90 patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for transurethral resection of unilateral lateral bladder wall tumors under spinal anesthesia.
Eligible patients will be randomly allocated into three groups of 30 patients each:
Group 1: Obturator nerve block (ONB) alone.
Group 2: Obturator nerve block combined with femoral nerve block (ONB + FNB).
Group 3: Obturator nerve block combined with femoral and sciatic nerve blocks (ONB + FNB + SNB).
The nerve blocks will be performed using ultrasound guidance according to the study protocol.
During surgery, the occurrence and severity of adductor muscle contractions associated with the obturator reflex will be recorded. Contractions will be classified as absent, mild, or severe according to their interference with the surgical procedure. The total number of contractions will also be documented.
Additional assessments will include block procedure duration, surgical duration, surgeon satisfaction using a 0-10 numerical scale, conversion to general anesthesia, bleeding, bladder injury, perforation, blood transfusion, and complications related to the nerve blocks.
The study aims to determine whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral bladder tumor resection.
- Conditions
- Obturator Reflex
- Being tested
- Obturator Nerve Block, Femoral Nerve Block, Sciatic Nerve Block
- Keywords
- Obturator Nerve Block, Femoral Nerve Block, Sciatic Nerve Block, Obturator Reflex Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator Nerve BlockProcedure or surgery
Ultrasound-guided obturator nerve block will be performed.
Femoral Nerve BlockProcedure or surgery
Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block.
Sciatic Nerve BlockProcedure or surgery
Ultrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks.
| Study group | Role | What they receive |
|---|---|---|
| Obturator Nerve Block (ONB) | Active comparator | Patients will receive an ultrasound-guided obturator nerve block. Receives: Procedure: Obturator Nerve Block |
| ONB + FNB | Experimental | Patients will receive ultrasound-guided obturator and femoral nerve blocks. Receives: Procedure: Obturator Nerve Block; Procedure: Femoral Nerve Block |
| ONB + FNB + SNB | Experimental | Patients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks. Receives: Procedure: Obturator Nerve Block; Procedure: Femoral Nerve Block; Procedure: Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
Participants experiencing at least one adductor muscle contraction during transurethral bladder tumor resection will be recorded. The number and proportion of affected participants will be compared across the three groups.
Measured: On the day of surgery, during transurethral tumor resection
Secondary outcomes (5)
Number of Participants With Severe Intraoperative Adductor Muscle Contractions
Adductor muscle contractions will be classified as severe if they interfere with the surgeon during resection. The number of participants experiencing at least one severe contraction will be recorded and compared across the three groups.
Measured: On the day of surgery, during transurethral tumor resection
Surgeon Satisfaction Score
Surgeon satisfaction will be assessed using a numerical rating scale from 0 (very poor) to 10 (excellent). Scores will be compared across the three groups.
Measured: At the end of surgery, on the day of the procedure
Total Number of Intraoperative Adductor Muscle Contractions
The total number of adductor muscle contractions occurring during transurethral bladder tumor resection will be recorded for each participant and compared across the three groups.
Measured: On the day of surgery, during transurethral tumor resection
Number of Participants With Bladder Wall Injury or Perforation
The occurrence of bladder wall injury or perforation during transurethral bladder tumor resection will be recorded and compared across the three groups.
Measured: On the day of surgery, during transurethral tumor resection
Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
Inability to continue surgical resection due to intraoperative adductor muscle contraction will be recorded and compared across the three groups.
Measured: On the day of surgery, during transurethral tumor resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obturator ReflexStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuna Erturk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuna Erturk, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Tuna Ertürk, MD, Principal investigator, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922941
- Sponsor's protocol ID
- 20-115
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block in Preventing the Obturator Reflex
- ClinicalTrials.gov ID
- NCT07922941
- Acronym / sponsor ID
- 20-115
- Conditions
- Obturator Reflex
- Keywords
- Obturator Nerve Block, Femoral Nerve Block, Sciatic Nerve Block, Obturator Reflex Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tuna ErturkUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 6 Nov 2026 (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 prospective, randomized controlled study aims to evaluate whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral resection of bladder tumors under spinal anesthesia.
Ninety patients will be randomly assigned to three groups: obturator nerve block alone, obturator plus femoral nerve blocks, or obturator plus femoral and sciatic nerve blocks. Adductor muscle contractions, surgeon satisfaction, procedure duration, and complications will be evaluated.
Detailed description
This single-center, prospective, randomized controlled study will include 90 patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for transurethral resection of unilateral lateral bladder wall tumors under spinal anesthesia.
Eligible patients will be randomly allocated into three groups of 30 patients each:
Group 1: Obturator nerve block (ONB) alone.
Group 2: Obturator nerve block combined with femoral nerve block (ONB + FNB).
Group 3: Obturator nerve block combined with femoral and sciatic nerve blocks (ONB + FNB + SNB).
The nerve blocks will be performed using ultrasound guidance according to the study protocol.
During surgery, the occurrence and severity of adductor muscle contractions associated with the obturator reflex will be recorded. Contractions will be classified as absent, mild, or severe according to their interference with the surgical procedure. The total number of contractions will also be documented.
Additional assessments will include block procedure duration, surgical duration, surgeon satisfaction using a 0-10 numerical scale, conversion to general anesthesia, bleeding, bladder injury, perforation, blood transfusion, and complications related to the nerve blocks.
The study aims to determine whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral bladder tumor resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obturator Nerve Block (ONB) | Active comparator | Procedure: Obturator Nerve BlockPatients will receive an ultrasound-guided obturator nerve block. |
| ONB + FNB | Experimental | Procedure: Obturator Nerve Block, Procedure: Femoral Nerve BlockPatients will receive ultrasound-guided obturator and femoral nerve blocks. |
| ONB + FNB + SNB | Experimental | Procedure: Obturator Nerve Block, Procedure: Femoral Nerve Block, Procedure: Sciatic Nerve BlockPatients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18-90 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for transurethral resection of unilateral lateral or inferolateral bladder wall tumors under spinal anesthesia.
- Patients providing informed consent personally or through a legally authorized representative.
- No known hypersensitivity to the medications used in the study.
Key exclusion criteria (7 listed)
- Age younger than 18 or older than 90 years.
- ASA physical status IV or higher.
- Absence of informed consent.
- Hypersensitivity to the study medications or their components.
- Infection or anatomical deformity at the nerve block sites.
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 BlockUltrasound-guided obturator nerve block will be performed. | Procedure or surgery | ONB + FNB, ONB + FNB + SNB, Obturator Nerve Block (ONB) |
| Femoral Nerve BlockUltrasound-guided femoral nerve block will be performed in addition to obturator nerve block. | Procedure or surgery | ONB + FNB, ONB + FNB + SNB |
| Sciatic Nerve BlockUltrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks. | Procedure or surgery | ONB + FNB + SNB |
Primary outcome
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
Time frame: On the day of surgery, during transurethral tumor resection
Participants experiencing at least one adductor muscle contraction during transurethral bladder tumor resection will be recorded. The number and proportion of affected participants will be compared across the three groups.
5 secondary outcomes
Number of Participants With Severe Intraoperative Adductor Muscle Contractions
Time frame: On the day of surgery, during transurethral tumor resection
Surgeon Satisfaction Score
Time frame: At the end of surgery, on the day of the procedure
Total Number of Intraoperative Adductor Muscle Contractions
Time frame: On the day of surgery, during transurethral tumor resection
Number of Participants With Bladder Wall Injury or Perforation
Time frame: On the day of surgery, during transurethral tumor resection
Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
Time frame: On the day of surgery, during transurethral tumor resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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TURBT
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.
Tuna Ertürk, MD principal investigator
University of Health Sciences Sultan 2. Abdulhamid Han 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 Obturator Nerve Block, Femoral Nerve Block and Sciatic Nerve Block in people with Obturator Reflex, run by Tuna Erturk 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuna Ertürk, MD (+905325010066, tunaerturk22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction (time frame: On the day of surgery, during transurethral tumor resection). 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 6 Nov 2026.