Cancer of BladderPhase 4NCT03063255
Comparison of Obturator Nerve Blockade and Neuromuscular Blockade
A Phase 4 study testing Obturator block and Neuromuscular block in people with Cancer of Bladder, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer of Bladder
- What is being tested?
- Obturator block and Neuromuscular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 19 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Planned TURBT for unilateral or bilateral posterolateral bladder tumors
- Ability to understand and provide informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
Official title: Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.
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.
Read the 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.
- Conditions
- Cancer of Bladder
- Being tested
- Obturator block, Neuromuscular block
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator blockDrug
Also called Ultrasound guided nerve block anesthetic, Mepivacaine, Pajunk SonoPlex needle
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 blockDrug
Also called Paralysis of the affected skeletal muscles anesthetic, Rocuronium
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.
| Study group | Role | What they receive |
|---|---|---|
| Obturator block | Active comparator | Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Receives: Drug: Obturator block |
| Neuromuscular block | Active comparator | Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Receives: Drug: Neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (2)
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.
Measured: Changes from baseline (pre-op) to 72 hours post-operative
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.
Measured: Changes from baseline (pre-op) to 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start25 Apr 2017
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of BladderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- José R Soberón, MD, Principal investigator, Malcom Randall VA Medical CenterBenjamin Canales, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063255
- Sponsor's protocol ID
- IRB201601962 -V
- Other IDs
- OCR18950
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2017
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33537703
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.
- ClinicalTrials.gov ID
- NCT03063255
- Acronym / sponsor ID
- IRB201601962 -V
- Conditions
- Cancer of Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.
| Arm | Type | Receives |
|---|---|---|
| Obturator block | Active comparator | Drug: Obturator blockComparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. |
| Neuromuscular block | Active comparator | Drug: Neuromuscular blockComparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years of age
- Planned TURBT for unilateral or bilateral posterolateral bladder tumors
- Ability to understand and provide informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obturator blockAlso: Ultrasound guided nerve block anesthetic, Mepivacaine, Pajunk SonoPlex needleSubjects 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. | Drug | Obturator block |
| Neuromuscular blockAlso: Paralysis of the affected skeletal muscles anesthetic, RocuroniumSubjects 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. | Drug | Neuromuscular block |
Primary outcome
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.
2 secondary outcomes
Number Patients With Increased Risk of Falling
Time frame: Changes from baseline (pre-op) to 72 hours post-operative
Number of Patients With Incidence of Leg Weakness
Time frame: Changes from baseline (pre-op) to 72 hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33537703Soberon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Soberón, MD principal investigator
Malcom Randall VA Medical Center
Benjamin Canales, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Obturator block and Neuromuscular block in people with Cancer of Bladder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Incidence of Intraoperative Adductor Spasm (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.