We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2022
First Posted Date  ICMJE March 29, 2022
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE February 15, 2022
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2022)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2022)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2022)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
Official Title  ICMJE Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Urethral Stricture, Male
Intervention  ICMJE
  • Drug: Standard Buccal Harvest
    Our institutions current anesthetic regimen. Comparison group
  • Drug: Basic buccal procedure + Long acting local
    Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
  • Drug: Basic buccal procedure + Buccal block
    Addition of long-acting local anesthetic as a buccal block after oral graft harvest
Study Arms  ICMJE
  • 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
    Intervention: Drug: Standard Buccal Harvest
  • 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
    Intervention: Drug: Basic buccal procedure + Long acting local
  • 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
    Intervention: Drug: Basic buccal procedure + Buccal block
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lindsay A Hampson, MD 415-353-2200 lindsay.hampson@ucsf.edu
Contact: Rory Grant (415) 353-7615 rory.grant2@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05300685
Other Study ID Numbers  ICMJE 21-35352
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lindsay Hampson, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP