Phase 4
N=60
Comparison of Obturator Nerve Blockade and Neuromuscular Blockade
Cancer of Bladder
Bottom Line
View on ClinicalTrials.gov: NCT03063255 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Patients With Incidence of Intraoperative Adductor Spasm — 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Obturator block (Drug); Neuromuscular block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Incidence of Intraoperative Adductor Spasm |
1; 5 | — |
| SECONDARY Number Patients With Increased Risk of Falling |
28; 29 | — |
| SECONDARY Number of Patients With Incidence of Leg Weakness |
27; 22 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03063255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.