Cancer of Bladder
Conditions
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.
Interventions
DRUGObturator 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.
DRUGNeuromuscular 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.
Sponsors
US Department of Veterans Affairs
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
The first subject enrolled was on 04/25/2017 and the last subject enrolled was on 6/11/2019. All subjects were enrolled at the Malcom Randall VAMC.
Participants by arm
| Arm | Count |
|---|---|
| Obturator Block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.
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. | 30 |
| Neuromuscular Block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.
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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Neuromuscular Block | Total | Obturator Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 52 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 8 Participants | 6 Participants |
| Age, Continuous | 72.2 years STANDARD_DEVIATION 6.3 | 71.3 years STANDARD_DEVIATION 6.8 | 70.2 years STANDARD_DEVIATION 7.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 60 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: intraoperative
Population: Data entry error correction, one patient withdrawn and only demographic information collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obturator Block | Number of Patients With Incidence of Intraoperative Adductor Spasm | 1 Participants |
| Neuromuscular Block | Number of Patients With Incidence of Intraoperative Adductor Spasm | 5 Participants |
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.
Time frame: Changes from baseline (pre-op) to 72 hours post-operative
Population: Data entry error correction, one patient withdrawn and only demographic information collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obturator Block | Number of Patients With Incidence of Leg Weakness | 27 Participants |
| Neuromuscular Block | Number of Patients With Incidence of Leg Weakness | 22 Participants |
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.
Time frame: Changes from baseline (pre-op) to 72 hours post-operative
Population: Data entry error correction, one patient withdrawn and only demographic information collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obturator Block | Number Patients With Increased Risk of Falling | 28 participants |
| Neuromuscular Block | Number Patients With Increased Risk of Falling | 29 participants |