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

NCT04885309 | Completed

• 1 other identifier: ONB2021
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-muscle invasive bladder cancer; Obturator nerve block; Transurethral resection

Outcome Measures

Primary Outcomes (1)

• Rate of Obturator Reflex

  Rate of patients who had an obturator reflex during the operation

  One year

Study Arms (2)

Obturator Nerve Block + Spinal Anaesthesia

ACTIVE COMPARATOR

Patients who underwent obturator nerve block with spinal anesthesia prior to TURBT

Procedure: Nerve Stimulator-guided Obturator Nerve Block

Spinal Anaesthesia

SHAM COMPARATOR

Patients who underwent spinal anesthesia prior to TURBT

Procedure: Nerve Stimulator-guided Obturator Nerve Block

Interventions

Nerve Stimulator-guided Obturator Nerve Block PROCEDURE

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.

Obturator Nerve Block + Spinal Anaesthesia; Spinal Anaesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lateral wall intermediate and high risk non-muscle invasive bladder cancer

You may not qualify if:

• Low risk non-muscle invasive bladder cancer
• Contraindications for spinal anesthesia
• History of allergy to local anesthetic agents
• Coagulopathy
• Neuromuscular diseases affecting the central nervous system
• Obturator nerve injury

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ali Kaan Yildiz

  Ankara Training and Resarch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: January 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)