Urinary Catheter Discomfort in Surgical Patients Clinical Trial
Official title:
Exploring the Potential Efficacy of Lidocaine Gel in Reducing Discomfort in Patients Undergoing Surgical Procedures Requiring Foley Catheter Placement
This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease pain and discomfort associate with Foley catheters upon awakening from general anesthesia in the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial colony counts from urine obtained from the surgical patients after insertion of the Foley catheter prior to prophylactic antimicrobial administration.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 19 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - Males requiring catheterization for surgical procedures scheduled for less than 4 hours. Exclusion Criteria: - Females, patients with preexisting urological conditions, and infections |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Creighton University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Decrease postoperative urinary catheter related discomfort | Subject and objective pain scale | Within 1 hour of emergence from general anesthetic | No |
| Secondary | decreased incidence of bacteriuria | Urine culture and colony counts | immediate post catheter insertion and at 2 hour time point | No |