NCT03063255

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Completed Phase 4 Results posted Last updated 24 March 2021

What this trial tests

Phase 4 trial testing Obturator block in Cancer of Bladder in 60 participants. Completed in 19 September 2019.

Timeline

25 April 2017

Primary endpoint
19 September 2019

19 September 2019

Quick facts

Lead sponsor	University of Florida
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	60
Start date	25 April 2017
Primary completion	19 September 2019
Estimated completion	19 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Obturator block — full drug profile →
• Neuromuscular block — full drug profile →

Conditions studied

• Cancer of Bladder — all drugs for Cancer of Bladder →

Sponsor

University of Florida

Who can join

Adults 18 to 90, any sex, with Cancer of Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Incidence of Intraoperative Adductor Spasm Primary · 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.

Group	Value	95% CI
Obturator Block	1
Neuromuscular Block	5

Number Patients With Increased Risk of Falling Secondary · 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.

Group	Value	95% CI
Obturator Block	28
Neuromuscular Block	29

Number of Patients With Incidence of Leg Weakness Secondary · 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.

Group	Value	95% CI
Obturator Block	27
Neuromuscular Block	22

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.