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Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block for Prevention of Obturator Reflex

2. november 2026 oppdatert av: Tuna Erturk

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34668
        • Sultan 2. Abdulhamid Han Training and Research Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Obturator Nerve Block (ONB)

Patients will receive an ultrasound-guided obturator nerve block.
Fremgangsmåte: Obturator Nerve Block

Ultrasound-guided obturator nerve block will be performed.
Eksperimentell: ONB + FNB

Patients will receive ultrasound-guided obturator and femoral nerve blocks.
Fremgangsmåte: Obturator Nerve Block

Ultrasound-guided obturator nerve block will be performed.

Fremgangsmåte: Femoral Nerve Block

Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block.
Eksperimentell: ONB + FNB + SNB

Patients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks.
Fremgangsmåte: Obturator Nerve Block

Ultrasound-guided obturator nerve block will be performed.

Fremgangsmåte: Femoral Nerve Block

Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block.

Fremgangsmåte: Sciatic Nerve Block

Ultrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Severe Intraoperative Adductor Muscle Contractions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Number of Participants With Bladder Wall Injury or Perforation
Tidsramme: 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
Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tuna Erturk

Etterforskere

  • Hovedetterforsker: Tuna Ertürk, MD, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. november 2026

Primær fullføring (Antatt)

2. februar 2027

Studiet fullført (Antatt)

2. februar 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 20-115

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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