Scrotum DiseasePhase 3NCT06242977
Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedures
A Phase 3 study testing Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA) in people with Scrotum Disease and Hydrocele Male, run by University of Manitoba at 1 site in Canada.
Trial summary
Scrotal, urologic surgery has traditionally been conducted in the hospital setting, typically with the use of sedation, spinal anesthesia or general anesthesia. There has been a recent push to move certain scrotal urologic surgeries out of the hospital operating room into a ambulatory, outpatient basis with recent… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Scrotum Disease, Hydrocele Male, Spermatocele
- What is being tested?
- Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2024to 30 Aug 2024
- Phase
- Phase 3
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing hydrocelectomy, spermatocelectomy, epididymectomy, testicular biopsy, scrotal lesion or cyst excision under local anesthesia alone were included.
Who cannot join
- Patients were excluded if their procedure was to be performed with sedatives (e.g., inhaled nitrous oxide gas, oral, or IV sedation) or did not provide consent to be randomized
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3
Premal Patel, MD, 204-221-4476, ppatel5@hsc.mb.ca
About this study
Official title: Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedure: A Randomized Controlled Study
Scrotal, urologic surgery has traditionally been conducted in the hospital setting, typically with the use of sedation, spinal anesthesia or general anesthesia. There has been a recent push to move certain scrotal urologic surgeries out of the hospital operating room into a ambulatory, outpatient basis with recent literature demonstrating this in many centers. The use of local anesthesia alone poses numerous benefits. The investigators wish to compare patients who are undergoing invasive scrotal surgery under local anesthetic to those who additionally have a topical anesthetic cream (EMLA) applied to the scrotum to determine if this further increases patient tolerability of these procedures.
Read the detailed description
The current standard of care for patients undergoing the majority of urologic procedures is to administer general or spinal anesthesia. The use of general or spinal anesthesia can lead to several complications, long wait times, higher costs associated with the operating. While office-based surgical procedures under local anesthesia can have additional benefits aside from avoiding adverse effects of spinal or general anesthesia, such as ability to communicate, improved convenience, and absence of extended post-op recovery. In one particular study, patients who were surveyed were overwhelmingly satisfied with office-based procedures, and often perceived office-based procedures as less invasive and safer. Urologic care has much to gain from expanding the use of procedures performed under local anesthetic in an ambulatory setting to address the above problems.
Although local anesthetic can be quite effective, needle phobia and negative experiences associated with it can be a common experience. In addition to the fear associated with injection, the traditional local anesthetic injection can also be associated with pain and trauma to the infiltrated site. EMLA (Eutectic Mixture of Local Anesthetic) is a topic anesthetic cream that has in various office based urology procedures. Its use and potential benefits has been seen in a few studies for use in no-scalpel vasectomy, circumcision, metatomy, and more. However its use in more involved/invasive andrology and male-infertility procedures such as hydrocelectomy, penile plications, and others remain poorly studied thus far. Anecdotally, use of EMLA cream as an adjunct to our local anesthetic protocol demonstrated good efficacy in pain control and patient tolerability.
As such, the investigators wish to perform a prospective randomized controlled study at the Manitoba Men's Health Clinic to assess whether or not the use of EMLA cream and local anesthetic nerve block is associated with improved pain tolerance than local anesthetic alone. If our hypothesis provides true, further implementation of EMLA cream in office based andrology and male-infertility procedures may provide better pain control and overall experience for patients.
- Being tested
- Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA), Control cream
- Medical subject headings
- Spermatocele, Hematocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA)Drug
Also called EMLA
The intervention is the utilization of EMLA cream, a topical anesthetic to determine if this reduces pain with local anesthesia infiltration, and for overall procedural pain
Control creamOther
Also called Moisturizing cream
This intervention will be for the control group, a simple lotion cream.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - EMLA cream | Experimental | This arm will receive EMLA cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite. Receives: Drug: Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA) |
| Control arm - Control cream | Placebo comparator | This arm will receive lotion cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite. Receives: Other: Control cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with local anesthetic infiltration
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient when the local anesthetic injection is administered
Measured: Immediately post-infiltration, intraoperatively
Procedural pain
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient post-operatively to determine their pain
Measured: Immediately post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start25 Jan 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scrotum DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, placebo controlled, randomized trial. Two arms, one is the intervention arm which will receive EMLA cream and local anesthesia infiltration while the control arm will receive local anesthesia infiltration and a control, lotion cream.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premal Patel, MD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242977
- Sponsor's protocol ID
- HS25862 (H2023:047)
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung D, Bal DS, Morra M, Shah J, Fidel MG, Dhillon H, Van Heerden H, Nayak JG, Patel P. Efficacy of EMLA for Office-based Andrology Procedures Under Local Anesthesia: A Randomized Control Trial. Urology. 2024 Oct;192:6-11. doi: 10.1016/j.urology.2024.07.004. Epub 2024 Jul 5.
PubMed 38972394
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06242977
- Acronym / sponsor ID
- HS25862 (H2023:047)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 Feb 2024 (actual)
- 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.
Scrotal, urologic surgery has traditionally been conducted in the hospital setting, typically with the use of sedation, spinal anesthesia or general anesthesia. There has been a recent push to move certain scrotal urologic surgeries out of the hospital operating room into a ambulatory, outpatient basis with recent literature demonstrating this in many centers. The use of local anesthesia alone poses numerous benefits. The investigators wish to compare patients who are undergoing invasive scrotal surgery under local anesthetic to those who additionally have a topical anesthetic cream (EMLA) applied to the scrotum to determine if this further increases patient tolerability of these procedures.
Detailed description
The current standard of care for patients undergoing the majority of urologic procedures is to administer general or spinal anesthesia. The use of general or spinal anesthesia can lead to several complications, long wait times, higher costs associated with the operating. While office-based surgical procedures under local anesthesia can have additional benefits aside from avoiding adverse effects of spinal or general anesthesia, such as ability to communicate, improved convenience, and absence of extended post-op recovery. In one particular study, patients who were surveyed were overwhelmingly satisfied with office-based procedures, and often perceived office-based procedures as less invasive and safer. Urologic care has much to gain from expanding the use of procedures performed under local anesthetic in an ambulatory setting to address the above problems.
Although local anesthetic can be quite effective, needle phobia and negative experiences associated with it can be a common experience. In addition to the fear associated with injection, the traditional local anesthetic injection can also be associated with pain and trauma to the infiltrated site. EMLA (Eutectic Mixture of Local Anesthetic) is a topic anesthetic cream that has in various office based urology procedures. Its use and potential benefits has been seen in a few studies for use in no-scalpel vasectomy, circumcision, metatomy, and more. However its use in more involved/invasive andrology and male-infertility procedures such as hydrocelectomy, penile plications, and others remain poorly studied thus far. Anecdotally, use of EMLA cream as an adjunct to our local anesthetic protocol demonstrated good efficacy in pain control and patient tolerability.
As such, the investigators wish to perform a prospective randomized controlled study at the Manitoba Men's Health Clinic to assess whether or not the use of EMLA cream and local anesthetic nerve block is associated with improved pain tolerance than local anesthetic alone. If our hypothesis provides true, further implementation of EMLA cream in office based andrology and male-infertility procedures may provide better pain control and overall experience for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blinded, placebo controlled, randomized trial. Two arms, one is the intervention arm which will receive EMLA cream and local anesthesia infiltration while the control arm will receive local anesthesia infiltration and a control, lotion cream.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - EMLA cream | Experimental | Drug: Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA)This arm will receive EMLA cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite. |
| Control arm - Control cream | Placebo comparator | Other: Control creamThis arm will receive lotion cream 30 minutes prior to their procedure, applied to the scrotum. The patient is blinded to which cream they have received and this cream is removed prior to entering the procedural suite. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing hydrocelectomy, spermatocelectomy, epididymectomy, testicular biopsy, scrotal lesion or cyst excision under local anesthesia alone were included.
Key exclusion criteria (1 listed)
- Patients were excluded if their procedure was to be performed with sedatives (e.g., inhaled nitrous oxide gas, oral, or IV sedation) or did not provide consent to be randomized
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 |
|---|---|---|
| Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA)Also: EMLAThe intervention is the utilization of EMLA cream, a topical anesthetic to determine if this reduces pain with local anesthesia infiltration, and for overall procedural pain | Drug | Intervention arm - EMLA cream |
| Control creamAlso: Moisturizing creamThis intervention will be for the control group, a simple lotion cream. | Other | Control arm - Control cream |
Primary outcome
Pain with local anesthetic infiltration
Time frame: Immediately post-infiltration, intraoperatively
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient when the local anesthetic injection is administered
Procedural pain
Time frame: Immediately post-operation
Using a visual analogue pain scale [range 0-10; 0 = no pain, 10 = maximal pain], pain will be assessed as reported by the patient post-operatively to determine their pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 38972394Chung D, Bal DS, Morra M, Shah J, Fidel MG, Dhillon H, Van Heerden H, Nayak JG, Patel P. Efficacy of EMLA for Office-based Andrology Procedures Under Local Anesthesia: A Randomized Control Trial. Urology. 2024 Oct;192:6-11. doi: 10.1016/j.urology.2024.07.004. Epub 2024 Jul 5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eutectic mixture of local anesthetics (EMLA; Astra Pharmaceutical Products Inc., Westborough, MA) in people with Scrotum Disease and Hydrocele Male, run by University of Manitoba at 1 site in Canada.
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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Premal Patel, MD (204-221-4476, ppatel5@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with local anesthetic infiltration (time frame: Immediately post-infiltration, intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242977, which also lists 1 linked publication.
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 5 Feb 2024.