Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block for Prevention of Obturator Reflex
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Tuna Ertürk, MD
- Numer telefonu: +905325010066
- E-mail: tunaerturk22@yahoo.com
Lokalizacje studiów
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Istanbul, Turcja (Türkiye), 34668
- Sultan 2. Abdulhamid Han Training and Research Hospital
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Kontakt:
- Hakan EMİRKADI, MD
- Numer telefonu: +905322609367
- E-mail: hemirkadi@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Obturator Nerve Block (ONB)
Patients will receive an ultrasound-guided obturator nerve block. |
Ultrasound-guided obturator nerve block will be performed. |
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Eksperymentalny: ONB + FNB
Patients will receive ultrasound-guided obturator and femoral nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. |
|
Eksperymentalny: ONB + FNB + SNB
Patients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. Ultrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
Ramy czasowe: 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. |
On the day of surgery, during transurethral tumor resection
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Severe Intraoperative Adductor Muscle Contractions
Ramy czasowe: On the day of surgery, during transurethral tumor resection
|
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. |
On the day of surgery, during transurethral tumor resection
|
|
Surgeon Satisfaction Score
Ramy czasowe: At the end of surgery, on the day of the procedure
|
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. |
At the end of surgery, on the day of the procedure
|
|
Total Number of Intraoperative Adductor Muscle Contractions
Ramy czasowe: On the day of surgery, during transurethral tumor resection
|
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. |
On the day of surgery, during transurethral tumor resection
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Number of Participants With Bladder Wall Injury or Perforation
Ramy czasowe: On the day of surgery, during transurethral tumor resection
|
The occurrence of bladder wall injury or perforation during transurethral bladder tumor resection will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
Ramy czasowe: On the day of surgery, during transurethral tumor resection
|
Inability to continue surgical resection due to intraoperative adductor muscle contraction will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Tuna Ertürk, MD, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 20-115
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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