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Completed

NCT Number: NCT03063255

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

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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Key information

Conditions

Cancer of Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obturator block

Drug

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.

Other names: Ultrasound guided nerve block anesthetic, Mepivacaine, Pajunk SonoPlex needle

Neuromuscular block

Drug

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.

Other names: Paralysis of the affected skeletal muscles anesthetic, Rocuronium

Primary outcomes

  1. Number of Patients With Incidence of Intraoperative Adductor Spasm

    Time frame: 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 outcomes

  1. Number Patients With Increased Risk of Falling

    Time frame: 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.

  2. Number of Patients With Incidence of Leg Weakness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2017
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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