Scrotum DiseasePhase 2NCT07192198
Efficacy of Inhaled Methoxyflurane (Penthrox) as Adjunct for Urologic Procedures Under Local Anesthetic: A Pilot Study
A Phase 2 study testing Methoxyflurane in people with Scrotum Disease and Hydrocele Male, run by University of Manitoba at 1 site in Canada.
Trial summary
We wish to perform a prospective randomized controlled pilot study at the Men's Health Clinic and Health Science's Centre to assess whether or not the use of Penthrox as an adjunct to LA is associated with improved pain tolerance and anxiety levels than local anesthetic alone 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?
- Methoxyflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2024to 19 Dec 2024
- Phase
- Phase 2
- 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 will be included.
Who cannot join
- Patients will be 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.
About this study
We wish to perform a prospective randomized controlled pilot study at the Men's Health Clinic and Health Science's Centre to assess whether or not the use of Penthrox as an adjunct to LA is associated with improved pain tolerance and anxiety levels than local anesthetic alone
Read the detailed description
This non-blinded, randomized controlled trial is to be conducted at both the Men's Health Clinic and Health Sciences Centre in Winnipeg, Manitoba. All eligible patients between the ages of 18-65, undergoing andrology and male infertility under local anesthetic or select endourology procedures under loco-sedation, will be invited to participate in the study. Patients will be excluded if; history of substance use disorder, history renal impairment, history of liver dysfunction, previous hypersensitivity to Penthrox or related agents, personal or family history of malignant hypothermia. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. For penoscrotal cases, patient will be randomized to Penthrox + local infiltration of 50/50 lidocaine and bupivacaine mixture vs local infiltration alone. For select endourology procedures, patients will be randomized to Penthrox + topical local anesthetic vs IV sedation + topical anesthetic. Participants may begin using the Penthrox 10 minutes prior to procedure start given its median time of onset of 5 minutes. In the post-operative recovery area, patient will be asked to complete a questionnaire related to pain and anxiety of procedure.
Baseline characteristics such as age, use of analgesics, prior history of procedure under loco-sedation, history of chronic pain, baseline pain level (Brief Pain Inventory), pre-procedural anxiety (State Trait Anxiety Inventory) will be collected.
- Being tested
- Methoxyflurane, Control
- Medical subject headings
- Spermatocele, Hematocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Penthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action.
ControlOther
This intervention will be the control group, only receiving local infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm-Penthrox | Experimental | Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes Receives: Drug: Methoxyflurane |
| Control arm | Placebo comparator | Patients in the control arm will only receive local infiltration. Receives: Other: Control |
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 posted25 Sep 2025
- Study start17 Apr 2024
- Primary completion27 Nov 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- 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 Penthrox and local anesthesia infiltration while the control arm will receive local anesthesia infiltration.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
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
- NCT07192198
- Sponsor's protocol ID
- HS26348
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled Methoxyflurane (Penthrox) as Adjunct for Urologic Procedures Under Local Anesthetic: A Pilot Study
- ClinicalTrials.gov ID
- NCT07192198
- Acronym / sponsor ID
- HS26348
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 25 Sep 2025 (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.
We wish to perform a prospective randomized controlled pilot study at the Men's Health Clinic and Health Science's Centre to assess whether or not the use of Penthrox as an adjunct to LA is associated with improved pain tolerance and anxiety levels than local anesthetic alone
Detailed description
This non-blinded, randomized controlled trial is to be conducted at both the Men's Health Clinic and Health Sciences Centre in Winnipeg, Manitoba. All eligible patients between the ages of 18-65, undergoing andrology and male infertility under local anesthetic or select endourology procedures under loco-sedation, will be invited to participate in the study. Patients will be excluded if; history of substance use disorder, history renal impairment, history of liver dysfunction, previous hypersensitivity to Penthrox or related agents, personal or family history of malignant hypothermia. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. For penoscrotal cases, patient will be randomized to Penthrox + local infiltration of 50/50 lidocaine and bupivacaine mixture vs local infiltration alone. For select endourology procedures, patients will be randomized to Penthrox + topical local anesthetic vs IV sedation + topical anesthetic. Participants may begin using the Penthrox 10 minutes prior to procedure start given its median time of onset of 5 minutes. In the post-operative recovery area, patient will be asked to complete a questionnaire related to pain and anxiety of procedure.
Baseline characteristics such as age, use of analgesics, prior history of procedure under loco-sedation, history of chronic pain, baseline pain level (Brief Pain Inventory), pre-procedural anxiety (State Trait Anxiety Inventory) will be collected.
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 Penthrox and local anesthesia infiltration while the control arm will receive local anesthesia infiltration.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm-Penthrox | Experimental | Drug: MethoxyfluraneParticipants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes |
| Control arm | Placebo comparator | Other: ControlPatients in the control arm will only receive local infiltration. |
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 will be included.
Key exclusion criteria (1 listed)
- Patients will be 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 |
|---|---|---|
| MethoxyfluranePenthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action. | Drug | Intervention arm-Penthrox |
| ControlThis intervention will be the control group, only receiving local infiltration. | Other | Control arm |
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methoxyflurane 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: finished, as of the sponsor's last update on 25 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 25 Sep 2025.