Bladder Cancer Clinical Trial

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Summary

Patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. Subjects will be randomized to receive an ultrasound-guided obturator block or a neuromuscular blocking agent after the induction of general anesthesia in an attempt to block the obturator reflex during surgery.

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Full Description

The purpose of this research is to compare the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents versus obturator block. Transurethral resection of bladder tumor(s) (TURBT) is a commonly performed procedure to diagnose and treat bladder cancer. The obturator nerve is located lateral to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh. Depending on the location of the tumor(s), electrocautery or surgical stimulation may result in stimulation of the obturator nerve, resulting in adduction of the leg, which is called the adductor reflex or spasm. This may occur violently and unexpectedly, and result in bladder perforation, bleeding, or cancer dissemination.

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Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 years of age
Planned TURBT for unilateral or bilateral posterolateral bladder tumors
Ability to understand and provide informed consent

Exclusion Criteria:

Patient refusal or inability to provide informed consent
True allergy, not sensitivity, to local anesthetics
True allergy, not sensitivity, Propofol
True allergy, not sensitivity, general anesthetic agents
Pregnancy
Severe hepatic impairment
Evidence of infection at or near the proposed needle insertion site
Any sensorimotor deficit of the lower extremity, whether acute or chronic
Inability to walk without assistance
Lower extremity joint replacement surgery in the preceding six months

Study is for people with:

Bladder Cancer

Phase:

Phase 4

Estimated Enrollment:

60

Study ID:

NCT03063255

Recruitment Status:

Completed

Sponsor:

University of Florida

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There is 1 Location for this study

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Malcom Randall VA Medical Center
Gainesville Florida, 32608, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 4

Estimated Enrollment:

60

Study ID:

NCT03063255

Recruitment Status:

Completed

Sponsor:


University of Florida

How clear is this clinincal trial information?

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