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

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


  • Org Study ID: IRB201601962 -V
  • Secondary ID:
  • NCT ID: NCT03063255
  • NCT Alias:
  • Sponsor: University of Florida - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting April 6, 2017 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Changes between the two group assessed by the intraoperative incidence of adductor spasm

Primary Outcome 1 - Time Frame: intraoperative

Condition:

  • Cancer of Bladder

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Official Information

Name: José R Soberón, MD

Role: Principal Investigator

Affiliation: Malcom Randall VA Medical Center

Overall Contact

Name: Judith Wishin, BSN

Phone: 352-273-9096

Email: jwishin@anest.ufl.edu

Location

Facility Status Contact
Malcom Randall VA Medical Center
Gainesville, Florida 32608
United States
Recruiting José R Soberón, MD
352-548-6000
jose.soberon@va.gov