Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Cancer of Bladder Clinical Trial

Official title:

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063255
• Other study ID #: IRB201601962 -V
• Secondary ID: OCR18950
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2017
• Est. completion date: September 19, 2019

Study information

• Verified date: March 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Bladder
• Urinary Bladder Neoplasms

Intervention

Drug:
• Obturator block
Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
• Neuromuscular block
Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Incidence of Intraoperative Adductor Spasm	Nerve Integrity Monitor will be used to detect adductor spasm and below are listed the numbers or patients with increased incidence of adductor spasm.	intraoperative
Secondary	Number Patients With Increased Risk of Falling	Based on TUG time measurements of patients below are the numbers of patients with an increased risk of falling.	Changes from baseline (pre-op) to 72 hours post-operative
Secondary	Number of Patients With Incidence of Leg Weakness	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.	Changes from baseline (pre-op) to 72 hours post-operative