Urinary Catheter Discomfort in Surgical PatientsPhase 4NCT02709304
Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients
A Phase 4 study testing Lidocaine gel and standard gel in people with Urinary Catheter Discomfort in Surgical Patients, run by Creighton University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Catheter Discomfort in Surgical Patients
- What is being tested?
- Lidocaine gel and standard gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males requiring catheterization for surgical procedures scheduled for less than 4 hours.
Who cannot join
- Females, patients with preexisting urological conditions, and infections
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Lidocaine gel, standard gel
- Keywords
- urinary catheter discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gelDrug
Also called Urojet
Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used
standard gelDrug
Standard gel that is used to insert a urinary catheter that does not contain local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Standard Gel | Placebo comparator | Standard gel not containing local anesthetic used to insert urinary catheters. Receives: Drug: standard gel |
| Lidocaine Gel | Experimental | lidocaine containing gel uses to insert urinary catheters Receives: Drug: Lidocaine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease postoperative urinary catheter related discomfort
Subject and objective pain scale
Measured: Within 1 hour of emergence from general anesthetic
Secondary outcomes (1)
decreased incidence of bacteriuria
Urine culture and colony counts
Measured: immediate post catheter insertion and at 2 hour time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Catheter Discomfort in Surgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark D Reisbig, MD PhD, Principal investigator, Creighton University School of Medicine / CHI Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709304
- Sponsor's protocol ID
- 693571
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential Efficacy of Lidocaine Gel in Reducing Discomfort in Patients Undergoing Surgical Procedures Requiring Foley Catheter Placement
- ClinicalTrials.gov ID
- NCT02709304
- Acronym / sponsor ID
- 693571
- Keywords
- urinary catheter discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Gel | Placebo comparator | Drug: standard gelStandard gel not containing local anesthetic used to insert urinary catheters. |
| Lidocaine Gel | Experimental | Drug: Lidocaine gellidocaine containing gel uses to insert urinary catheters |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males requiring catheterization for surgical procedures scheduled for less than 4 hours.
Key exclusion criteria (1 listed)
- Females, patients with preexisting urological conditions, and infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine gelAlso: UrojetGel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used | Drug | Lidocaine Gel |
| standard gelStandard gel that is used to insert a urinary catheter that does not contain local anesthetic | Drug | Standard Gel |
Primary outcome
Decrease postoperative urinary catheter related discomfort
Time frame: Within 1 hour of emergence from general anesthetic
Subject and objective pain scale
1 secondary outcome
decreased incidence of bacteriuria
Time frame: immediate post catheter insertion and at 2 hour time point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Urinary Catheter Discomfort in Surgical Patients
RecruitingPhase 4
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Urinary Catheter, Catheter-related Bladder Discomfort
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Reisbig, MD PhD principal investigator
Creighton University School of Medicine / CHI Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine gel and standard gel in people with Urinary Catheter Discomfort in Surgical Patients, run by Creighton University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark D Reisbig, MD PhD (402-449-4847, mdr44643@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease postoperative urinary catheter related discomfort (time frame: Within 1 hour of emergence from general anesthetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.