Urethral Stricture, MalePhase 3BuccalNCT05300685
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
A Phase 3 study testing Standard Buccal Harvest, Basic buccal procedure + Long acting local and Basic buccal procedure + Buccal block in people with Urethral Stricture, Male, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture, Male
- What is being tested?
- Standard Buccal Harvest, Basic buccal procedure + Long acting local and Basic buccal procedure + Buccal block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2022to 1 Sep 2026
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, age 18 or older
- Undergoing anterior urethroplasty with buccal grafting
- Able to consent
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Francisco
San Francisco, California, 94143
MedStar Urology
Washington D.C., District of Columbia, 20037
About this study
Official title: Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
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.
Read the 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
- Conditions
- Urethral Stricture, Male
- Being tested
- Standard Buccal Harvest, Basic buccal procedure + Long acting local, Basic buccal procedure + Buccal block
- Keywords
- buccal urethroplasty, urethral stricture, urethroplasty, buccal block, lidocaine
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Buccal HarvestDrug
Our institutions current anesthetic regimen. Comparison group
Basic buccal procedure + Long acting localDrug
Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
Basic buccal procedure + Buccal blockDrug
Addition of long-acting local anesthetic as a buccal block after oral graft harvest
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard of care | Active comparator | 1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
2. Routine, standard graft site hemostasis with monopolar cautery
3. No suture closure of graft site
4. No further infiltration of local anesthetic in mouth Receives: Drug: Standard Buccal Harvest |
| Group 2: Standard of care + Long acting local | Experimental | 1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
2. Routine, standard graft site hemostasis with monopolar cautery
3. No suture closure of graft site
4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site Receives: Drug: Basic buccal procedure + Long acting local |
| Group 3: Standard of care + Buccal block | Experimental | 1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
2. Routine, standard graft site hemostasis with monopolar cautery
3. No suture closure of graft site
4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block Receives: Drug: Basic buccal procedure + Buccal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative Day 1, 5, 10
Secondary outcomes (1)
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)
Measured: Postoperative Day 1, 5, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Feb 2022
- Primary completion1 May 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urethral Stricture, MaleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- MedStar Georgetown University Hospital
- Responsible party
- Sponsor
- Investigators
- Lindsay Hampson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300685
- Sponsor's protocol ID
- 21-35352
- Acronym
- Buccal
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31057252Rourke 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.
PubMed 22119261Lumen 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.
PubMed 22889835
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
- ClinicalTrials.gov ID
- NCT05300685
- Acronym / sponsor ID
- Buccal / 21-35352
- Conditions
- Urethral Stricture, Male
- Keywords
- buccal urethroplasty, urethral stricture, urethroplasty, buccal block, lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- MedStar Georgetown University Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 29 Mar 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard of care | Active comparator | Drug: Standard Buccal Harvest1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL 2. Routine, standard graft site hemostasis with monopolar cautery 3. No suture closure of graft site 4. No further infiltration of local anesthetic in mouth |
| Group 2: Standard of care + Long acting local | Experimental | Drug: Basic buccal procedure + Long acting local1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL 2. Routine, standard graft site hemostasis with monopolar cautery 3. No suture closure of graft site 4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site |
| Group 3: Standard of care + Buccal block | Experimental | Drug: Basic buccal procedure + Buccal block1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL 2. Routine, standard graft site hemostasis with monopolar cautery 3. No suture closure of graft site 4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men, age 18 or older
- Undergoing anterior urethroplasty with buccal grafting
- Able to consent
Key exclusion criteria (13 listed)
- Taking chronic opiates for pain
- Diagnosis of chronic pain
- Prior buccal urethroplasty
- Vulnerable population (e.g. prisoner)
- Renal dysfunction or allergy preventing NSAID use
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 |
|---|---|---|
| Standard Buccal HarvestOur institutions current anesthetic regimen. Comparison group | Drug | Group 1: Standard of care |
| Basic buccal procedure + Long acting localAddition of long-acting local anesthetic to the wound bed following the oral graft harvest. | Drug | Group 2: Standard of care + Long acting local |
| Basic buccal procedure + Buccal blockAddition of long-acting local anesthetic as a buccal block after oral graft harvest | Drug | Group 3: Standard of care + Buccal block |
Primary outcome
Change(s) in Post-operative pain
Time frame: 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).
1 secondary outcome
Change(s) in Post-operative Narcotic use
Time frame: Postoperative Day 1, 5, 10
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 10 Sep 2026.
- Background: PubMed 31057252Jonnavithula 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.
- Background: PubMed 22119261Rourke 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.
- Background: PubMed 22889835Lumen 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.
- 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.
Lindsay Hampson, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Buccal Harvest, Basic buccal procedure + Long acting local and Basic buccal procedure + Buccal block in people with Urethral Stricture, Male, run by University of California, San Francisco at 2 sites in United States.
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 3 inclusion and 13 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change(s) in Post-operative pain (time frame: Postoperative Day 1, 5, 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300685, which also lists 3 linked publications.
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 10 Sep 2026.