Scrotum Disease, Hydrocele Male, Spermatocele, Scrotal Hematocele, Anesthesia, Local
Conditions
Brief 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
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.
Interventions
DRUGMethoxyflurane
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.
OTHERControl
This intervention will be the control group, only receiving local infiltration.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The surgeon and patient are both blinded to which cream is being utilized, whether it be Penthrox, or a control. Investigators and study personnel are not blinded to this.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients undergoing hydrocelectomy, spermatocelectomy, epididymectomy, testicular biopsy, scrotal lesion or cyst excision under local anesthesia alone will be included.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with local anesthetic infiltration | 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 | 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 |
Countries
Canada
Outcome results
None listed