Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

NCT03063255 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB201601962 -VOCR18950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  intraoperative

Secondary Outcomes (2)

• Number Patients With Increased Risk of Falling

  Changes from baseline (pre-op) to 72 hours post-operative

• Number of Patients With Incidence of Leg Weakness

  Changes from baseline (pre-op) to 72 hours post-operative

Study Arms (2)

Obturator block

ACTIVE COMPARATOR

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

Drug: Obturator block

Neuromuscular block

ACTIVE COMPARATOR

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

Drug: Neuromuscular block

Interventions

Obturator block DRUG

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.

Also known as: Ultrasound guided nerve block anesthetic, Mepivacaine, Pajunk SonoPlex needle

Obturator block

Neuromuscular block DRUG

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.

Also known as: Paralysis of the affected skeletal muscles anesthetic, Rocuronium

Neuromuscular block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• Planned TURBT for unilateral or bilateral posterolateral bladder tumors
• Ability to understand and provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 33537703 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mepivacaine; Neuromuscular Blockade; Rocuronium

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia; Investigative Techniques; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jose R. Soberon, Jr.
• Organization: Department of Anesthesiology, NF/SG Veterans Health System

jsoberon@anest.ufl.edu

352-413-2317

Study Officials

• José R Soberón, MD

  Malcom Randall VA Medical Center

  PRINCIPAL INVESTIGATOR

• Benjamin Canales, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sixty subjects with be randomized to the obturator block or neuromuscular block arm upon enrollment, using randomized permutated blocks of six.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 24, 2017
• Study Start: April 25, 2017
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)