Clinical trial NCT03063255: Comparison of Obturator Nerve Blockade and Neuromuscular Blockade
Official title: Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer of Bladder
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2017-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Number of Patients With Incidence of Intraoperative Adductor Spasm
timeFrame: intraoperative
Secondary outcomes:
measure: Number Patients With Increased Risk of Falling
timeFrame: Changes from baseline (pre-op) to 72 hours post-operative
measure: Number of Patients With Incidence of Leg Weakness
timeFrame: Changes from baseline (pre-op) to 72 hours post-operative
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: Malcom Randall VA Medical Center
name: José R Soberón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Benjamin Canales, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soberon JR, Awoniyi CA, Perez MA, Vasilopoulos T, Canales BK. Obturator Nerve Blockade vs. Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors: A Randomized Controlled Trial. Pain Med. 2021 Jun 4;22(6):1253-1260. doi: 10.1093/pm/pnaa448.