Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03063255
• Collaborator: US Department of Veterans Affairs (U.S. Fed)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Bladder	Drug: Obturator block; Drug: Neuromuscular block	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.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)
• Primary Purpose: Basic Science
• Official Title: Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Sep 19, 2019
• Actual Study Completion Date: Sep 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Obturator block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.	Drug: 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.; Other Names: Ultrasound guided nerve block anesthetic Mepivacaine Pajunk SonoPlex needle
Active Comparator: Neuromuscular block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.	Drug: 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.; Other Names: Paralysis of the affected skeletal muscles anesthetic Rocuronium

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malcom Randall VA Medical Center	Gainesville	Florida	United States	32608

Sponsors and Collaborators

• University of Florida
• US Department of Veterans Affairs

Investigators

• Principal Investigator: José R Soberón, MD, Malcom Randall VA Medical Center
• Principal Investigator: Benjamin Canales, MD, University of Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 25, 2016
• Informed Consent Form - Oct 25, 2018

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03063255
• Other Study ID Numbers: IRB201601962 -V; OCR18950
• First Posted: Feb 24, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Anesthetics; Mepivacaine; Rocuronium

Study Results

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.

Arm/Group Title	Obturator Block	Neuromuscular Block
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	30	30
COMPLETED	29	30
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Obturator Block	Neuromuscular Block	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 20%	2 6.7%	8 13.3%
>=65 years	24 80%	28 93.3%	52 86.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.2 (7.3)	72.2 (6.3)	71.3 (6.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	30 100%	30 100%	60 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Incidence of Intraoperative Adductor Spasm
Description	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

Outcome Measure Data

Analysis Population Description

Data entry error correction, one patient withdrawn and only demographic information collected

Arm/Group Title	Obturator Block	Neuromuscular Block
Arm/Group Description	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.	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.
Measure Participants	29	30
Count of Participants [Participants]	1 3.3%	5 16.7%

2. Secondary Outcome

Title	Number Patients With Increased Risk of Falling
Description	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

Outcome Measure Data

Analysis Population Description

Data entry error correction, one patient withdrawn and only demographic information collected

Arm/Group Title	Obturator Block	Neuromuscular Block
Arm/Group Description	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.	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.
Measure Participants	29	30
Number [participants]	28 93.3%	29 96.7%

3. Secondary Outcome

Title	Number of Patients With Incidence of Leg Weakness
Description	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

Outcome Measure Data

Analysis Population Description

Data entry error correction, one patient withdrawn and only demographic information collected

Arm/Group Title	Obturator Block	Neuromuscular Block
Arm/Group Description	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.	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.
Measure Participants	29	30
Count of Participants [Participants]	27 90%	22 73.3%

Adverse Events

Time Frame	For the overall study adverse events were recorded over 1 year and 2 months. Each subject was followed for AE's per protocol.
Arm/Group Title	Obturator Block		Neuromuscular Block
Arm/Group Description	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.		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.
All Cause Mortality
	Obturator Block		Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)
Serious Adverse Events
	Obturator Block		Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Obturator Block		Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.