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Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours

NCT04885309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-05-13

No results posted yet for this study

Summary

In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need for second transurethral resection of bladder tumours (TURBT) and postoperative complications were investigated in patients who underwent TURBT for intermediate and high risk lateral wall non-muscle invasive bladder tumours (NMIBC).

Conditions

  • Bladder Cancer Stage 0
  • Bladder Cancer Stage I

Interventions

PROCEDURE

Nerve Stimulator-guided Obturator Nerve Block

Following the confirmation of spinal anesthesia level in the patients in the ONB group while in the lithotomy position, ONB was applied unilaterally or bilaterally, depending on the tumor position. A needle with a nerve stimulator was advanced vertically 2 cm below and 2 cm from the pubic tubercle. The needle is inserted through the skin and into the lower ramus of the pubic bone. When contraction was observed in the adductor muscle groups and the aspiration was negative, 10 mL 0.25% levobupivacaine at 0.3-0.5 mA was administered. The operation was started 10 minutes after the injection. TURBT operations were performed with a 30 degree optic and a 26 F bipolar resectoscope. All spinal anesthesia and ONB procedures were performed by the same anesthesia team. All TURBT operations were performed by the same surgeon.

Sponsors & Collaborators

  • Ankara Training and Research Hospital

    lead OTHER

Principal Investigators

  • Ali Kaan Yildiz · Ankara Training and Resarch Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-04-01
Completion
2021-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885309 on ClinicalTrials.gov