Anesthetic Protocols for Oral Pain After Urethral Surgery

(Buccal Trial)

Recruiting at 1 trial location

Overseen By Rory Grant

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for oral pain after urethral surgery?

Research shows that using local anesthesia, like lidocaine with adrenaline, for buccal mucosa grafts can reduce the need for general anesthesia, which is beneficial for patients. Additionally, infraorbital nerve blocks have been found effective in reducing pain at the donor site after surgery. ^{1 2 3 4 5}

Is buccal mucosa graft urethroplasty with local anesthesia safe?

Research shows that using local anesthesia for buccal mucosa graft urethroplasty is generally safe, though it requires patient cooperation and can avoid the risks associated with general anesthesia. Some studies mention potential complications like pain, numbness, and difficulty with mouth opening, but these are typically manageable. ^{1 2 3 6 7}

How does the treatment for oral pain after urethral surgery differ from other treatments?

This treatment is unique because it uses local anesthesia techniques, like buccal block and long-acting local anesthesia, to manage pain during and after urethral surgery, reducing the need for general anesthesia and potentially minimizing recovery time and complications. ^{1 2 3 5 6}

Research Team

Lindsay A Hampson, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Harvesting buccal mucosa graft under local infiltration analgesia--mitigating need for general anesthesia. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Autologous buccal mucosa harvest under local anesthesia: Feasibility, safety, and acceptance for substitution urethroplasty. [2022]

3. India 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oral complications after buccal mucosal graft harvest for urethroplasty. [2022]

5. India 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. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Buccal Mucosal Graft Urethroplasty in Patients Awaiting Renal Transplantation. [2022]