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Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty (Buccal)

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ClinicalTrials.gov Identifier: NCT05300685
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Urethral Stricture, Male Drug: Standard Buccal Harvest Drug: Basic buccal procedure + Long acting local Drug: Basic buccal procedure + Buccal block Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1: Standard of care
  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
 Drug: Standard Buccal Harvest
Our institutions current anesthetic regimen. Comparison group
Experimental: Group 2: Standard of care + Long acting local
  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
 Drug: Basic buccal procedure + Long acting local
Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
Experimental: Group 3: Standard of care + Buccal block
  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
 Drug: Basic buccal procedure + Buccal block
Addition of long-acting local anesthetic as a buccal block after oral graft harvest


Outcome Measures
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Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Change(s) in Post-operative Narcotic use [ Time Frame: Postoperative Day 1, 5, 10 ]
    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)


Other Outcome Measures:
  1. Peri-operative Complications [ Time Frame: Postoperative Day 0-30 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05300685


Contacts
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Contact: Lindsay A Hampson, MD 415-353-2200 lindsay.hampson@ucsf.edu
Contact: Rory Grant (415) 353-7615 rory.grant2@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Lindsay A Hampson, MD    415-353-2200    lindsay.hampson@ucsf.edu   
Sub-Investigator: Nathan M Shaw, MD         
Principal Investigator: Lindsay A Hampson, MD         
Sub-Investigator: Benjamin N Breyer, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Lindsay Hampson, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] February 8, 2022

More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05300685    
Other Study ID Numbers: 21-35352
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
buccal urethroplasty
urethral stricture
urethroplasty
buccal block
lidocaine
Additional relevant MeSH terms:
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Urethral Stricture
Constriction, Pathologic
Pathological Conditions, Anatomical
 Urethral Obstruction
Urethral Diseases
Urologic Diseases