Anesthetic Protocols for Oral Pain After Urethral Surgery

(Buccal Trial)

Recruiting at 2 trial locations

Overseen By Sara Z Amare, BS

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of California, San Francisco

Must not be taking: Chronic opiates

Disqualifiers: Chronic pain, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Immediate peri-operative period

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates which method best controls mouth pain after buccal urethroplasty, a surgery using mouth tissue to repair part of the urinary tract. It compares three pain management techniques: usual care, a long-acting local anesthetic, and a buccal block (a numbing shot in the mouth). Men undergoing this surgery who can give consent may be suitable for the trial. The goal is to determine which method most effectively reduces pain without causing additional mouth issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking chronic opiates for pain or have certain allergies that prevent the use of specific medications like NSAIDs or Tylenol.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using tissue from the inside of the cheek for urethra repair surgery is generally safe. In a study with 102 patients, this procedure was performed without major problems, demonstrating its feasibility and safety. Another study found that using cheek tissue in surgeries did not increase complications, even when patients were discharged the same day.

For the pain relief methods tested in this trial, bupivacaine, a long-lasting local painkiller, is commonly used and generally well-tolerated. It is recommended to use it with lidocaine to manage pain when harvesting cheek tissue. The buccal block, another method using bupivacaine, has been used safely in many cases without increasing complications.

These findings suggest that the procedures and pain relief methods in the trial are likely safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these anesthetic protocols for oral pain after urethral surgery because they offer new ways to manage pain more effectively. The standard treatment involves using lidocaine with epinephrine, but these new protocols explore the addition of long-acting bupivacaine. One approach uses bupivacaine directly at the graft site for prolonged pain relief, while another uses it as a buccal block to numb a larger area, potentially reducing the need for additional pain medication. These innovations could lead to improved patient comfort and quicker recovery times.

What evidence suggests that this trial's anesthetic protocols could be effective for oral pain after urethral surgery?

Research has shown that long-lasting local pain relief can help manage mouth pain after buccal graft surgery. In this trial, participants in Group 2 will receive standard care plus long-acting local anesthesia, which studies have shown results in only mild pain, indicating these pain relievers can effectively reduce discomfort.

Additionally, participants in Group 3 will receive a buccal block, a type of local pain relief, which may reduce the need for painkillers after surgery. A recent trial showed that patients required fewer painkillers after receiving liposomal bupivacaine, a type of buccal block. Overall, both treatments in this trial appear to provide significant pain relief for patients undergoing this type of surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Lindsay A Hampson, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older who are undergoing anterior urethroplasty with buccal grafting and can consent. It's not for those with certain blood conditions, anesthetic complications, chronic pain issues, severe heart problems (NYHA Class III/IV), liver or kidney dysfunctions that prevent the use of common pain relievers, allergies to specific mouthwashes or local anesthetics, prisoners, or anyone previously treated with buccal urethroplasty.

Inclusion Criteria

I am a man aged 18 or older.

I am having surgery to repair my urethra using tissue from my mouth.

Able to consent

Exclusion Criteria

Vulnerable population (e.g. prisoner)

You are allergic to Peridex or Magic Mouthwash.

My blood condition prevents me from having surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo buccal urethroplasty with one of three anesthetic protocols: standard of care, long-acting local, or buccal block

Immediate peri-operative period

1 visit (in-person)

Follow-up

Participants are monitored for post-operative pain and complications using the Wong-Baker FACES pain scale and Clavien-Dindo classification

4 weeks

3 visits (in-person) on Postoperative Day 1, 5, 10

Long-term follow-up

Participants are monitored for any long-term complications or outcomes

Up to 30 days post-operation

What Are the Treatments Tested in This Trial?

Interventions

• Basic buccal procedure + Buccal block
• Basic buccal procedure + Long acting local
• Standard Buccal Harvest

Trial Overview The study tests three anesthesia methods for managing oral pain after a surgery involving a cheek tissue graft in the urethra. Patients will be randomly assigned to receive either a basic procedure plus a buccal block, standard harvest technique without additional blocks, or basic procedure plus long-acting local anesthesia. The goal is to see which method best reduces post-op pain.

How Is the Trial Designed?

Group I: Group 3: Standard of care + Buccal block Experimental Treatment 1 Intervention

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

Group II: Group 2: Standard of care + Long acting local Experimental Treatment 1 Intervention

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

Group III: Group 1: Standard of care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

MedStar Georgetown University Hospital

Collaborator

Trials

6

Recruited

22,900+

Published Research Related to This Trial

The use of infraorbital nerve block (IOB) significantly reduces postoperative pain and facilitates earlier oral intake of liquids and solids after buccal mucosal graft urethroplasty, with patients in the IOB group able to eat liquids in 1 day compared to 2-5 days in the control group.

At one-month follow-up, the IOB group experienced less perioral numbness and pain on mastication compared to the control group, indicating that IOB may help reduce long-term complications associated with the donor site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of infraorbital nerve block on postoperative pain and 30-day morbidity at the donor site in buccal mucosal graft urethroplasty. Jonnavithula, N., Bachu, D., Sriramoju, V., et al.[2022]

In a study of 13 patients awaiting renal transplantation, buccal mucosal graft urethroplasty showed a relatively high complication rate, including bleeding, urinary extravasation, and infections, with one patient succumbing to sepsis post-surgery.

Despite the complications, the procedure demonstrated stable urinary flow rates (Qmax) over a year, suggesting that while risks are present, the surgery can still provide functional benefits for patients with urethral strictures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buccal Mucosal Graft Urethroplasty in Patients Awaiting Renal Transplantation. Pal, BC., Modi, PR., Modi, JD., et al.[2022]

In a study of 30 patients who underwent buccal mucosal graft harvesting for urethroplasty, most experienced minimal oral pain shortly after surgery, with 90% able to eat and drink by discharge.

Despite high satisfaction rates (74% would choose the procedure again), long-term complications such as oral numbness (16% of patients) and tightness of the mouth (32% of patients) were reported, indicating the need for thorough patient education about potential outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral complications after buccal mucosal graft harvest for urethroplasty. Dublin, N., Stewart, LH.[2022]

Buccal mucosal graft urethroplasty can be performed using a local anesthesia technique with 2% lidocaine and adrenaline, which minimizes the need for general anesthesia.

This local anesthesia method reduces the overall morbidity associated with general anesthesia, making the procedure safer for patients who can cooperate during the graft harvesting process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harvesting buccal mucosa graft under local infiltration analgesia--mitigating need for general anesthesia. Goel, A., Dalela, D., Sinha, RJ., et al.[2022]

A study involving 102 patients showed that harvesting buccal mucosa under local anesthesia for urethroplasty is safe and feasible, with no conversions to general anesthesia required during the procedure.

Over 90% of patients found the procedure easy to tolerate and would be willing to undergo it again, indicating high acceptability and minimal complications, with only one case of bothersome hemorrhage reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous buccal mucosa harvest under local anesthesia: Feasibility, safety, and acceptance for substitution urethroplasty. Ajape, AA., Kuranga, SA., Kura, MM., et al.[2022]

Buccal mucosal graft (BMG) harvest for urethroplasty is associated with significant postoperative pain, with 83% of patients reporting pain, and 51% experiencing worse pain than expected.

Leaving the donor site open after BMG harvest results in less postoperative pain compared to closing the site, suggesting that nonclosure may be a better approach to minimize discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain. Wood, DN., Allen, SE., Andrich, DE., et al.[2022]

In a study of 93 patients undergoing urethroplasty with buccal mucosal grafting, systemic, epidural, and intrathecal morphine provided similar quality of recovery (QoR) scores, indicating that all three analgesic methods are effective for pain management post-surgery.

However, the intrathecal morphine group experienced a higher incidence of postoperative nausea and vomiting (PONV) and pruritis, suggesting that while it is effective, it may have more side effects compared to the other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative administration of systemic/epidural/intrathecal morphine on the quality of recovery following substitutional urethroplasty with buccal mucosal graft: A randomized control trial. Johnson, JPJ., Arumugam, R., Karuppusami, R., et al.[2023]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/85/NCT05300685/ICF_000.pdf

Peri-operative oral pain control following buccal graft ... Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. The purpose of this study is to assess three ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10057861/

Narcotic Requirements before and after Implementation of ... A recent randomized trial demonstrated reduction in acute post-operative narcotic use following liposomal bupivacaine infiltration to the buccal ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05300685

Peri-operative Oral Pain Control Following Buccal Graft ... This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial. ...

4. withpower.com withpower.com/trial/phase-3-urethral-stricture-1-2022-458d7

Anesthetic Protocols for Oral Pain After Urethral Surgery A study involving 102 patients showed that harvesting buccal mucosa under local anesthesia for urethroplasty is safe and feasible, with no conversions to ...

5. tau.amegroups.org tau.amegroups.org/article/view/101283/html

Pain management strategies in urethral reconstruction Postoperative pain was significantly higher between postoperative day 2 and 7 for the patients who underwent bilateral buccal graft harvest ...

6. ctv.veeva.com ctv.veeva.com/study/peri-operative-oral-pain-control-following-buccal-graft-urethroplasty

Peri-operative Oral Pain Control Following Buccal Graft ... Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6995930/

Outpatient buccal mucosal graft urethroplasty outcomes ... BMG urethroplasty can be safely performed in an ambulatory setting without increased complications or compromised outcomes.

8. mdpi.com mdpi.com/2673-4397/5/3/16

Buccal Mucosa Graft in Urological Surgery: A State-of-the- ... They showed that upper lip graft is safe and easy to obtain with a limited complication rate, even if it provides a limited amount of tissue for urethral ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2590089724000069

Bulbourethral dorsal onlay buccal mucosal graft urethroplasty Satisfaction outcomes at 3, 6 and 12 months postoperatively. Satisfaction scores rose from 87 % to 94 %. Conclusion. Primary outcomes match international data ...