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| Name | Class |
|---|---|
| MedStar Georgetown University Hospital | OTHER |
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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.
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
Group 2: Basic buccal procedure + Long acting local
Group 3: Basic buccal procedure + Buccal block
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Standard of care | Active Comparator |
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| Group 2: Standard of care + Long acting local | Experimental |
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| Group 3: Standard of care + Buccal block | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Buccal Harvest | Drug | Our institutions current anesthetic regimen. Comparison group |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative Complications | Clavien-Dingo is a validated tool to measure the severity of post-operative outcomes. Class I are mild and require no treatment. Class V is death. | Postoperative Day 0-30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay A Hampson, MD | Contact | 415-353-2200 | lindsay.hampson@ucsf.edu | |
| Sara Z Amare, BS | Contact | (415) 514-7597 | sara.amare@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Hampson, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31057252 | Background | Jonnavithula N, Bachu D, Sriramoju V, Devraj R, Gunta R, Pisapati MVLN. Effect of infraorbital nerve block on postoperative pain and 30-day morbidity at the donor site in buccal mucosal graft urethroplasty. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):114-118. doi: 10.4103/joacp.JOACP_211_17. | |
| 22119261 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2022 | Feb 14, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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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.
| Basic buccal procedure + Long acting local | Drug | Addition of long-acting local anesthetic to the wound bed following the oral graft harvest. |
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| Basic buccal procedure + Buccal block | Drug | Addition of long-acting local anesthetic as a buccal block after oral graft harvest |
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| MedStar Urology | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
|
| Rourke K, McKinny S, St Martin B. Effect of wound closure on buccal mucosal graft harvest site morbidity: results of a randomized prospective trial. Urology. 2012 Feb;79(2):443-7. doi: 10.1016/j.urology.2011.08.073. Epub 2011 Nov 25. |
| 22889835 | Background | Lumen N, Oosterlinck W, Hoebeke P. Urethral reconstruction using buccal mucosa or penile skin grafts: systematic review and meta-analysis. Urol Int. 2012;89(4):387-94. doi: 10.1159/000341138. Epub 2012 Aug 9. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |