Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Phase 4

Completed

• Conditions: Cancer of Bladder
• Interventions: Drug: Neuromuscular block; Drug: Obturator block

• Registration Number: NCT03063255
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-24
• Study Start: 2017-04-25
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Results First Submitted: 2020-09-14
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Results First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular block	Neuromuscular block	Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.
Obturator block	Obturator block	Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Incidence of Intraoperative Adductor Spasm	intraoperative	Nerve Integrity Monitor will be used to detect adductor spasm and below are listed the numbers or patients with increased incidence of adductor spasm.

Secondary Outcome Measures

Name	Time	Method
Number Patients With Increased Risk of Falling	Changes from baseline (pre-op) to 72 hours post-operative	Based on TUG time measurements of patients below are the numbers of patients with an increased risk of falling.
Number of Patients With Incidence of Leg Weakness	Changes from baseline (pre-op) to 72 hours post-operative	Test the strength of subject's lower extremity muscles on the timed up and go (TUG) test and determine how many patients had increased leg weakness.

Trial Locations

Locations (1)

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States