Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Study Overview
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Brief Summary
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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
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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

Official Title
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Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic

Conditions
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Urethral Stricture, Male

Intervention / Treatment
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* Drug: Standard Buccal Harvest
* Drug: Basic buccal procedure + Long acting local
* Drug: Basic buccal procedure + Buccal block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Standard of care<br>Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site No further infiltration of local anesthetic in mouth | Drug: Standard Buccal Harvest<br>* Our institutions current anesthetic regimen. Comparison group<br>|
| Experimental: Group 2: Standard of care + Long acting local<br>Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site | Drug: Basic buccal procedure + Long acting local<br>* Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.<br>|
| Experimental: Group 3: Standard of care + Buccal block<br>Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block | Drug: Basic buccal procedure + Buccal block<br>* Addition of long-acting local anesthetic as a buccal block after oral graft harvest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(s) in Post-operative pain | 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). | Postoperative Day 1, 5, 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(s) in Post-operative Narcotic use | 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) | Postoperative Day 1, 5, 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buccal urethroplasty, urethral stricture, urethroplasty, buccal block, lidocaine