Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

University of Florida

Status and phase: Completed; Phase 4

Conditions: Cancer of Bladder

Treatments: Drug: Obturator block; Drug: Neuromuscular block

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03063255

IRB201601962 -V

OCR18950 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Obturator block

Active Comparator group

Description:

Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.

Treatment:

Drug: Obturator block

Neuromuscular block

Active Comparator group

Description:

Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.

Treatment:

Drug: Neuromuscular block