Urethral Stricture, Male
Conditions
Keywords
buccal urethroplasty, urethral stricture, urethroplasty, buccal block, lidocaine
Brief summary
Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial. Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.
Detailed description
This is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). This study will aim to assess three established anesthetic protocols for oral pain control. Each study arm holds equal weight. Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care. Group 1: Current Buccal Harvest * Infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site Group 2: Basic buccal procedure + Long acting local * Infiltration of lidocaine 1% with epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site * 0.5% Marcaine (maximum 5cc) at case conclusion Group 3: Basic buccal procedure + Buccal block * Infiltration of lidocaine 1% with epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site * Buccal block with 0.5% Marcaine (maximum 5cc) at case conclusion
Interventions
DRUGStandard Buccal Harvest
Our institutions current anesthetic regimen. Comparison group
DRUGBasic buccal procedure + Long acting local
Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
DRUGBasic buccal procedure + Buccal block
Addition of long-acting local anesthetic as a buccal block after oral graft harvest
Sponsors
University of California, San Francisco
MedStar Georgetown University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive 3 different local anesthetic regimens following buccal graft harvest. The care provider administering will not be masked to the type of block, but they will be blinded to the post op outcomes.
Intervention model description
This is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). This study will aim to assess three established anesthetic protocols for oral pain control. Each study arm holds equal weight.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men, age 18 or older * Undergoing anterior urethroplasty with buccal grafting * Able to consent
Exclusion criteria
* Taking chronic opiates for pain * Diagnosis of chronic pain * Prior buccal urethroplasty * Vulnerable population (e.g. prisoner) * Renal dysfunction or allergy preventing NSAID use * Liver dysfunction or allergy preventing Tylenol use * Medical allergy to local anesthetic * Medical allergy to Peridex/Magic Mouthwash * NYHA Class III/IV * Hematologic condition that excludes patient from surgery * Post-operative complication resulting in inpatient stay * Anesthetic complication * No buccal site surgical complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change(s) in Post-operative pain | Postoperative Day 1, 5, 10 | The Wong-Baker FACES pain scale is a validated scale where a score of 0 is no pain and 10 is the worst pain imaginable. Pain greater than or equal to 5 would result in significant limitations on daily life. Oral, incisional (surgical site), and overall pain will each be assigned a score of 0-10 at each time point (9 total scores). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change(s) in Post-operative Narcotic use | Postoperative Day 1, 5, 10 | Patient measure of number of oxycodone tablets taken (0-5). Patient request for additional narcotic medicaiton (Yes/No) Patient measure of adherence to non-narcotic pain regiman (Yes/No) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLindsay Hampson, MD
University of California, San Francisco
Outcome results
None listed