search
Back to results

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Primary Purpose

Cancer of Bladder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Obturator block
Neuromuscular block
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cancer of Bladder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Malcom Randall VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Obturator block

Neuromuscular block

Arm Description

Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.

Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 8, 2017
Last Updated
March 22, 2021
Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT03063255
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Bladder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obturator block
Arm Type
Active Comparator
Arm Description
Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.
Arm Title
Neuromuscular block
Arm Type
Active Comparator
Arm Description
Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.
Intervention Type
Drug
Intervention Name(s)
Obturator block
Other Intervention Name(s)
Ultrasound guided nerve block anesthetic, Mepivacaine, Pajunk SonoPlex needle
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Neuromuscular block
Other Intervention Name(s)
Paralysis of the affected skeletal muscles anesthetic, Rocuronium
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José R Soberón, MD
Organizational Affiliation
Malcom Randall VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Canales, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33537703
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.
Results Reference
derived

Learn more about this trial

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

We'll reach out to this number within 24 hrs